Field Safety Notice Vygon Lifecath Biflux Double Lumen Catheter FSU129 (ICN 2870)

NHSSC: 95

Alert:

• Vygon has issued an Advisory Field Safety Notice, to inform customers of an increase of customer reports in the UK relating to catheter fractures and malfunction of the pinch clamps on the catheter, specifically product code FSU129.
• After excessive use of the clamps and when closed for long periods (as described within clinical guidelines), in a few cases the clamps may open spontaneously.
• Lifecath catheters are made from Silicone. Silicone is also a delicate material, and even minor damage can lead to a catheter fracture.
• This information is to raise awareness that the recommended handling of Lifecath catheters differs in some respects from common clinical practice.
• The supplier can confirm that no root cause has been identified and there have been no changes to the materials nor the manufacturing process within the last three years.

Products Affected:

• The affected product is available via NHS Supply Chain:

•  The affected product is currently suspended and unavailable to order. This is due to an existing supply issue.
• See our Useful Links section to review ICN 2695 for currently availability and potential indirect alternatives.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Th supplier confirms that the use of the product does not need to change if none of the possible handling problems stated with the notice have occurred.
• There is no requirement for customers to return any devices. Lifecath catheters can continue to be used in accordance with the IFU and the advisory FSN.
• Complete the FSN Email Back Form, found on page 5 of the notice and return to: technical-uk@vygon.com.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.