Urgent Field Safety Notice – POLYPERF

Urgent Field Safety Notice – POLYPERF

For Attention of*: Identify either by name or role who needs to be aware of the hazard and/or take action. If this is multiple recipients then include full list.

Contact details of local representative (name, e-mail, telephone, address etc.)*
Technical Department – technical-uk@vygon.com, Tel: 01794 748800 – Vygon (UK) Ltd, The Pierre Simonet Building, V Park, Gateway North, Latham Road, Swindon, SN25 4DL

FSN Ref: 2507/51830/00 – CAPA25-037 Rev00 EN: FSCA Ref 2507/51830/00 – CAPA25-037 Rev00 EN:

Urgent Field Safety Notice (FSN)
Device Commercial Name
Risk addressed by FSN

1. Information on Affected Devices*

1.Device Type(s)* – POLYPERF needles are curved Huber needles with a connecting line (tubing). They are available in various lengths and diameters and with or without a side injection site.

2. Commercial name(s) – POLYPERF

3. Unique Device Identifier(s) (UDI-DI)* – N/A

4. Primary clinical purpose of device(s)* – Needles indicated for the administration or withdrawal of fluids through implantable catheter ports

5. Device Model/Catalogue/part number(s)* –
Product code – Commercial Name – LOT number
VPE581709 – POLYPERF W/O Y 0.9D X 17MM 20G – 24075013
VPE581709 – POLYPERF W/O Y 0.9D X 17MM 20G – 24085061
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24065182
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24075215
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105076
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105111
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105167
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105185
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105254
VPE582509 – POLYPERF W/O Y 0.9D X 25MM 20G – 24055165
VPE582509 – POLYPERF W/O Y 0.9D X 25MM 20G – 24065177

6.Software version – N/A

7. Affected serial or lot number range
Product code – Commercial Name – LOT number
VPE581709 – POLYPERF W/O Y 0.9D X 17MM 20G – 24075013
VPE581709 – POLYPERF W/O Y 0.9D X 17MM 20G – 24085061
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24065182
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24075215
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105076
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105111
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105167
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105185
VPE582009 – POLYPERF W/O Y 0.9D X 20MM 20G – 24105254
VPE582509 – POLYPERF W/O Y 0.9D X 25MM 20G – 24055165
VPE582509 – POLYPERF W/O Y 0.9D X 25MM 20G – 24065177

8. Associated devices – N/A

2. Reason for Field Safety Corrective Action (FSCA)*

1. Description of the product problem* – The legal manufacturer (PEROUSE MEDICAL) has identified a potential defect on some rigid blisters of POLYPERF products after sterilization. A very small number of blister packs may have localised cracks on the corners. This could result in a breach of the products’ sterile barrier system.

2. Hazard giving rise to the FSCA* – Breakage of the sterile barrier system may result in contamination of the medical device and lead to an infectious risk for the patient

3. Probability of problem arising – Batches involved have a blister crack/leak rate between 0.06% and 1.17%.

4. Predicted risk to patient/users – Breakage/rupture of the sterile barrier system may result in contamination of the medical device and lead to an infectious risk for the patient

5. Further information to help characterise the problem – N/A

6. Background on Issue – The legal manufacturer (PEROUSE MEDICAL) has identified a potential defect on some rigid blisters of POLYPERF products after sterilization. A very small number of blister
packs may have localised cracks on the corners. This could result in a breach of the products’ sterile barrier system

7. Other information relevant to FSCA – N/A

3. Type of Action to mitigate the risk*

1. Action To Be Taken by the User*
☒ Identify Device
☒ Quarantine Device
☒ Return Device
☐ Destroy Device
☐ On-site device modification/inspection
☐ Follow patient management recommendations
☐ Take note of amendment/reinforcement of Instructions For Use (IFU)
☐ Other
☐ None
Provide further details of the action(s) identified

2. By when should the action be completed? – 6th August 2025

3. Particular considerations for: N/A

4. Is customer Reply Required? * (If yes, form attached specifying deadline for return) – Yes

5. Action Being Taken by the Manufacturer
☒ Product Removal
☐ On-site device modification/inspection
☐ Software upgrade
☐ IFU or labelling change
☐ Other
☐ None

Provide further details of the action(s) identified.

6. By when should the action be completed? – Specify where critical to patient/end user safety

7. Is the FSN required to be communicated to the patient /lay user? – No

8. If yes, has manufacturer provided additional information suitable for the patient/lay user in a patient/lay or non-professional user information letter/sheet? – N/A

4. General Information*

1. FSN Type* – New

2. For updated FSN, reference number and date of previous FSN – N/A

3. For Updated FSN, key new information as follows:  N/A

4. Further advice or information already expected in follow-up FSN? * -No

5. If follow-up FSN expected, what is the further advice expected to relate to: – N/A

6. Anticipated timescale for follow-up FSN – N/A

7. Manufacturer information (For contact details of local representative refer to page 1 of this FSN)
a. Company Name – Vygon (UK) Ltd (on behalf of PEROUSE MEDICAL)
b. Address – The Pierre Simonet Building, V Park, Gateway North, Latham Road, Swindon, Wiltshire, SN25 4DL
c. Website address – www.vygon.co.uk

8.The Regulatory Authority of your country has been informed about this communication to customers. *

9.List of attachments/appendices: – Appendix 1: Instructions for use (set-up of the enteral feeding set) Appendix 2: Cover change Acknowledgement of receipt

10. Name/Signature – Kate O’Connell, Technical Support Manager (On behalf of Jules Peacemaker
Harelimana, Quality PMS Manager)

Transmission of this Field Safety Notice

This notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. (As appropriate)
Please transfer this notice to other organisations on which this action has an impact. (As appropriate)
Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
Please report all device-related incidents to the manufacturer, distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback..*