Field Safety Notice Philips Foetal Spiral Electrode Needle Tip Breaking (ICN 1937)

Alert:

• Philips has issued an Urgent Field Safety Notice after becoming aware of a potential safety issue with the Foetal Spiral Electrode (FSE) based on complaints related to the spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient.
• The FSE may also break off if the user pulls the spiral tip from the foetal skin, increasing the risk of the spiral tip detaching from the FSE during removal.
• The Foetal Spiral Electrode is intended for patients requiring foetal heart rate monitoring during labour.
• As a result, Philips has decided to discontinue the distribution of this product.

Products Affected:

•  The product was available from NHS Supply Chain as:

• Please note due to Philips’ decision to discontinue these electrodes, customers will need to consider alternative products as these NPCs will be deactivated.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• If you have unused products requiring a credit, contact your local NHS Supply Chain Customer Service Advisor with the full details of the affected products including NPC, lot numbers, quantity (eaches or boxes of 25, unit of issue). Your Advisor will give you a unique (CMS) reference and advise next steps.
• FDK1266 supplied on the eDirect route will be collected direct from your trust by Cardiac Services Chris Collins Telephone 01625 878 999 email c-collins@cardiac-services.com
• FDK404 supplied on the Blue Diamond route will be returned to NHS Supply Chain for full credit using reason code 7 “Supplier Recall”. All goods must be returned by Friday 20 January 2023.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.