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Quality & Innovation in Healthcare
 

Healthcare Alerts

The healthcare alerts featured are issued by either the NPSA or MHRA.

We are publishing them to improve the awareness of important issues in clinical practice and product use.


Posted 04-January-2010 

Off-label Use of Medical Devices

The Medical Devices Regulations (that implement the relative Directive) stipulate that the manufacturer of a

device is responsible for establishing that the device is safe and that it is suitable for its intended purpose.

To establish this, manufacturers implement appropriate controls on the device design and manufacture, and

evaluate the safety and performance of the device in its intended application. This involves an analysis of

risks that could arise during use, an assessment of relevant pre-clinical and clinical data, the preparation of

appropriate instructions for use and, if necessary, specific training schemes. From such activities,

manufacturers are able to verify that risks have been eliminated or minimised and are judged acceptable

when weighed against the anticipated benefits to patients.

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Posted 18-September-2015 

FIELD SAFETY CORRECTIVE ACTION (FSCA)

Product Code: 0884.08 (FSW576)
 
Lot/Batch Number: 021214EG, 100315EG, 090615EG, 170615EG
 
Following the previous recall in July, a further two further batch numbers have been found to be affected by an intermittent manufacturing defect and there is a possibility that the Y connector could be blocked.  We are therefore having to undertake further FSCA and the Field Safety Notice (FSN) has been updated and sent to all potentially affected customers.  Please find attached a copy of the FSN and the fax/email back form.

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Posted 11-August-2015 

FIELD SAFETY NOTICE PREMICATH+STYLET+MICROFLASH INTRO

FIELD SAFETY NOTICE
PREMICATH+STYLET+MICROFLASH INTRO
FSN – Identifier: 1504/33989/00
Type of Action: AWARENESS
Details of Affected Devices:
Product Code: 1261208 (FSU263)
Lot Number(s): ALL
Background
Vygon has supplied the small 1Fr Premicath neonatal catheter in the UK for approximately twenty years. Initially, the catheter was supplied with a splitting needle introducer, and this remains popular today. As wire technologies improved, a styletted version of Premicath was introduced into the UK in 2004. The Premicath with stylet allowed a slightly softer catheter material to be used and more challenging insertions were successful.
Vygon monitor the performance of the product in the market and actively encourage reporting of any untoward event. Whilst there have been no significant changes in the total number of reported adverse events, there has been an increase in fractures within the range of styletted catheters in the UK and the US. This variation in reports has prompted a review of the Premicath range, in terms of materials, manufacturing process, changes in clinical practice and equipment and instructions for use.
With such a small plastic tube (Ø 0.35 mm) and such fragile patients, it can be argued that some complications are inevitable. Some of these can be predicted and steps taken to reduce associated risks, an example being tip location and avoiding risk of pericardial effusion or tamponade1 whilst some may occur unexpectedly. Historically, we consider the following to be the most common causes of catheter fracture;

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Posted 07-May-2015 

What are FSNs and FSCAs by the MHRA

The MHRA has just published a notice to the NHS explaining what FSNs and FSCAs are. It is to encourage them to pay attention to notices from manufacturers and tells them why it is so important. It is a very short document, with big letters, so please take a moment to read it and encourage your customers to do the same.

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Posted 17-September-2014 

Urgent Field Safety Corrective Action

16th September 2014

MULTICATH EXPERT 5LUMEN 9.5FG/16CMS

FSCA – Identifier: 1409/32597/12

Type of Action: RECALL DEVICE

Details of Affected Devices:

Product Code: 8159.167

Lot/Batch Number: 020414GE

Description of Problem

Approximately 148 x incorrect catheters (Size: 8.5fr, 12.5cm, 4 x lumens) have been supplied within product code: 8159.167, batch number: 020414GE. This manufacturing related error may result in the following risks:

  • Incorrect Positioning – due to the decreased length of the incorrectly supplied catheters, the catheter tip may not reach the desired position/location during placement
  • Insufficient Lumens – the incorrect catheters incorporate four lumens. Therefore, an additional catheter or extension set may be required following placement to establish five routes of access 

 

Field Safety Corrective Action Instructions: 

Advice on action to be taken by Medical Staff

  1. Identify and quarantine any remaining stock of 8159.167, 020414GE.
  2. If you do not have stock from the affected batch number, stated above, mark the according checkbox on the enclosed FSCA Fax Back Form, complete the form and send it to the following fax number: 01793 748899 or email: technical@vygon.co.uk. 
  3. If you have stock from the affected batch number, stated above, mark the according checkbox on the enclosed FSCA Fax Back Form, provide the additional information requested and send the completed form to the following fax number: 01793 748899 or email: technical@vygon.co.uk. 
  4. On receipt of the completed FSCA Fax Back Form, a Vygon (UK) Ltd. representative will contact you to arrange return of the affected stock and replacement products from an alternative batch number. 
  5. Please complete actions by 31st October 2014.  

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Posted 07-January-2013 

Field Safety Corrective Action (Recall)

3rd January 2013

URGENT FIELD SAFETY CORRECTIVE ACTION
RYLES TUBE (WEIGHTED TIP) 12FG 125CM

FSCA – Identifier: 1212/29183/16
Type of Action: RECALL
Details of Affected Devices:
Product Code: 0392.12
Lot Number: 160412FG

Description of Problem
It has been identified that, due to a production error, the depth markings have been incorrectly applied to a number of tubes of this batch number.
During use, the inserted length of tube indicated by the markings would be incorrect and this could result in misplacement of the feeding tube.

Field Safety Corrective Action Instructions:
Advice on action to be taken by Medical Staff

1. Identify and quarantine any remaining stock of product 0392.12, batch number: 160412FG.
2. If you do not have stock from the affected batch number, stated above, mark the according checkbox on the enclosed FSCA Fax Back Form, complete the form and send it to the following fax number: 01793 748899 or email: technical@vygon.co.uk.
3. If you have stock from the affected batch number, stated above, mark the according checkbox on the enclosed FSCA Fax Back Form, provide the additional information requested and send the completed form to the following fax number: 01793 748899 or email: technical@vygon.co.uk.
4. On receipt of the completed FSCA Fax Back Form, a Vygon (UK) Ltd. representative will contact you to arrange return of the affected stock and replacement products from an alternative batch number.

Instruction for Distributors of affected batch numbers
If you are a distributor, please provide this Field Safety Corrective Action (FSCA) to all your customers who have received products of the affected batch number, as stated above. Please send your customers the following documents:
 A copy of this Field Safety Corrective Action
 A copy of the FSCA Fax Back Form
The FSCA Fax Back Form should be completed by your customer and returned to you.
As a distributor you are required to confirm to Vygon (UK) Ltd that you have completed the instructed activity for all of your customers affected by this Field Action. Please forward all completed FSCA Fax Back Forms to the following fax number: 01793 748899 or email: technical@vygon.co.uk
Please also identify and quarantine any remaining stock of the affected batch number in your warehouse, complete the FSCA Fax Back Form and forward it to the following fax number: 01793 748899 or email: technical@vygon.co.uk.
On receipt of the completed FSCA Fax Back Form, a Vygon (UK) Ltd. representative will contact you to arrange return of the affected stock and replacement products from an alternative batch number.
Vygon (UK) Ltd
Vygon (UK) Ltd has informed all customers, employees of Vygon (UK) Ltd and distributors of this Field Safety Corrective Action.

Transmission of this Field Safety Corrective Action
This notice needs to be passed on to all recipients of this product within your organisation, in particular, the following:
All Wards
Risk Managers
Health and Safety Managers
Purchasing Managers
Medical Directors
Nursing Directors
ITU Directors
A&E Directors
Maternity Units
Critical Care Units
Nutrition & Dietetics
Radiology
Please consider end users, clinicians, risk managers, supply chain/distribution centres etc. in the circulation of this notice.
Please maintain awareness of this FSCA and resulting action for an appropriate period to ensure effectiveness of the corrective action.

Contact Person
Should you require any further information or support concerning this issue, please contact:

Kate O’Connell
Technical Support Department
Vygon (UK) Ltd
The Pierre Simonet Building
V Park, Gateway North
Latham Road
Swindon
Wiltshire
SN25 4DL
Telephone: 01793 748800

Vygon (UK) Ltd. apologise for any inconvenience this FSCA may cause.
This Field Safety Notice has been communicated to the MHRA
Kate O’Connell
Laboratory Supervisor
Email: kate.oconnell@vygon.co.uk

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Posted 24-August-2012 

Central venous and haemodialysis catheters manufactured by Arrow

Risk of severe anaphylactic reaction if these devices are used in patients with an allergy to chlorhexidine, silver sulfadiazine, and/or sulfa drugs.

The contraindication for patients with known hypersensitivity does not appear on the package lid, but is included in the Instructions for Use that accompany each device. However, unless these are consulted, the device may be inadvertently used in a patient with a known allergy

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Posted 05-July-2012 

URGENT - FIELD SAFETY NOTICE

Vygon Bionector S and Aurum, pre-filled, glass syringes.

FSCA – Identifier: 1205/28138/08
201/007/004/601/008

Details of Affected Devices:

Aurum glass syringes & Vygon Bionector S

Vygon Product Codes:

841.233, 841235E, 841.265, 841266E, 841.365,
85222.01C, 852201F, 896.21 & 896.23

Description of Problem: Aurum, pre-filled, glass syringe incompatibility with Bionector S

Vygon (UK) Ltd has received reports of Aurum pre-filled glass syringes breaking when being connected directly onto Bionector S. Our investigation has identified a large variation in size of the internal diameter of the syringe luer tip with some of them being smaller than the internal lumen of the Bionector S, this can cause difficult connection resulting in:

• damage to the Bionector S or the pre-filled syringe
• fragments of glass blocking the syringe flow
• delay in the administration of medicines when resuscitating patients

Please see below for further information.

Action

• use Vygon adaptor (ATP431) or
• remove Bionector S or extension line with Bionector S prior to use with pre-filled syringes

Further information:

Following a detailed validation process, for a number of years Vygon (UK) Ltd. has supplied Bionector S for use with glass, pre-filled syringes as the internal lumen is smaller than that of the standard Bionector. Our original compatibility testing showed that the smaller Bionector S internal lumen was compatible with the internal diameter of the tested syringe tip. Since receiving the above reports, we have conducted further tests on syringes that are currently being supplied to the marketplace and have identified tolerances in the internal lumen of the pre-filled syringes of up to 40% with some being smaller than the fixed sized lumen of the Bionector S, thus preventing correct connection.


There is currently no ISO standard that covers the specification of internal diameters of male luer connectors.

Although it would appear that the majority of the pre-filled syringes connect without problem, the risk to the patient is high if the connection fails. Because of this, Vygon (UK) Ltd. has decided to advise that these products are no longer compatible without the use of an adaptor.

Vygon (UK) Ltd offers complimentary adaptors for use with Bionector/Bionector S and pre-filled syringes, please contact our Customer Service Department (Tel: 01793 748800) for details.

Vygon (UK) Ltd. would like to advise that we supplied these products as compatible following extensive testing and without knowledge of the recently identified wide tolerances in the internal diameters of the pre-filled syringes.

Transmission of this Field Safety Notice

This notice needs to be passed on to all recipients of this product within your organisation, in particular, the following:

All departments and wards using I.V. access devices and pre-filled syringes
Resuscitation Officers
A&E Directors
ITU Directors
Risk Managers
Health and Safety Managers
Purchasing Managers
Medical Directors
Nursing Directors

Please maintain awareness of this FSN and resulting action for an appropriate period to ensure effectiveness of the corrective action.

Contact Person

Dawn Chivers
QA/RA Manager
Vygon (UK) Ltd.
The Pierre Simonet Building
V Park, Gateway North
Latham Road, Swindon
Wiltshire
SN25 4DL

Telephone: 01793 748800

Vygon (UK) Ltd. sincerely apologises for any inconvenience that this Field Safety Notice may cause.

This Field Safety Notice has been communicated to the MHRA


For and on behalf of Vygon (UK) Ltd.

Dawn Chivers
Quality Assurance & Regulatory Affairs Manager
 

 

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Posted 26-March-2012 

Prevention of over infusion of intravenous fluid and medicines in neonates

There is a risk of the accidental over infusion of intravenous fluids and medicines to neonates associated with the setting up of specific intravenous infusions or the overriding of safety mechanisms on infusion pumps. This risk has the potential to result in death.

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Posted 20-March-2012 

Residual anaesthetic drugs in cannulae

After intravenous anaesthesia, small amounts of the agent may be left in the cannula which is then flushed into the patient when further fluid or medication is given intravenously through the same cannula. This may happen when ward staff give antibiotics or pain relief after the patient returns from theatre.

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Posted 01-December-2011 

Product recall notice

Vygon has issued the following product recall notice on Octopus three lumen with anti-reflux valves. It has been identified that, due to a production error, there may be a number of products of batch number 080411AE, which may incorporate an anti-syphon valve instead of an anti-reflux valve.

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Posted 16-August-2011 

Needle-free intravenous connectors

The MHRA issued MDA/2004/005 in January 2004 to raise awareness of incompatibility between some needle-free connectors and Luer tips of pre-filled syringes.

The MHRA continues to receive reports of damage to the needle-free connector and/or to the pre-filled syringe where force has been used to connect incompatible devices together. In some cases fragmentsmay block the syringe outflow. Such damage has resulted in a delay in administering therapy during the resuscitation of patients.

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Posted 12-August-2011 

Reducing the harm caused by misplaced nasogastric feeding tubes

PSA/002

This Alert updates and strengthens Patient Safety Alert 05 (Reducing the harm caused by misplaced nasogastric feeding tubes) and is based on national learning since then.

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Posted 10-June-2011 

Safer spinal, epidural and regional devices

PSA/001

There have been fatal cases where intravenous medicines have been administered by the spinal (intrathecal) route, and where epidural medicines have been administered by the intravenous (vein) route. There is also the potential for medicines intended for regional anaesthesia to be administered by the intravenous route, with fatal outcomes.

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Posted 10-June-2011 

Risk of back-tracking when an IV line has multiple access ports

MDA/2010/073

The MHRA continues to receive reports of incidents involving intravenous (IV) extension sets with multiple ports. These incidents have led to serious consequences e.g. patients receiving an inadvertent bolus of anaesthetic agent due to back-tracking, resulting in respiratory arrest.

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