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Quality & Innovation in Healthcare
 

FIELD SAFETY NOTICE 

Posted by Vygon (UK) Ltd  on 18-August-2015 
FIELD SAFETY NOTICE

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


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;
 Tensile fracture – Catheter being pulled beyond its elastic limits. This may occur when the baby is being moved during routine care, a dressing is being changed/removed or the baby may catch the catheter with a leg or arm.
 Over-pressure during infusion – Use of higher pressure than recommended (1.5bar, 21.7psi).
 Weakened catheter material – Most commonly seen when the catheter comes into contact with a solution that contains alcohol (ChloraPrep® or similar).
RA-049 Issue 1
 Catheter securement – Direct application of steristrips to the catheter. Inadequate fixation allowing frequent flexing. Changes in use or type of semi-occlusive dressings.
 Insertion method – Use of alternate introducers.

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