Safety Alert Aurum Pre-Filled Syringes Phased Introduction of New 10ml CONNECT Syringe Barrel: Importance of Selecting Compatible Needle Free Connectors to Minimise the Risk of Syringe Blockage (ICN 3015)

NHSSC: 49

Alert:

• The MHRA has issued a Device Safety Information Notice, DSI 2025 02, to make healthcare professionals aware of the importance of using connectors which are compatible with the Aurum new connect syringe barrel.
• Due to a phased introduction of the new 10ml CONNECT barrel design for the Aurum pre-filled syringes, the range of compatible needle free connectors (NFCs) differs between the established syringe barrel and the new syringe barrel.
• It is vital that healthcare professionals use compatible NFCs with Aurum pre-filled syringes to prevent delays to delivery of emergency medication.
• The MHRA advise the use of incompatible needle-free connectors (NFCs) with Aurum pre-filled syringes has led to adverse incidents in emergency situations.
• Attaching an incompatible NFC can block the syringe and prevent delivery of emergency medicine.
• A new 10ml barrel design for the Aurum pre-filled syringes, CONNECT, will be compatible with a wider range of NFCs to minimise the occurrence of these adverse incidents. For the transition period, both the new syringe and the established syringe will be available for affected products.
• The CONNECT syringe will be introduced to the market in a phased manner:
  • The 10ml CONNECT barrel for the Adrenaline 1:10,000 pre-filled syringe is scheduled for market introduction in July 2025
  • This will be followed by the phased rollout of the 10ml CONNECT barrel for the Amiodarone and Calcium Chloride pre-filled syringe products.
• All NFCs compatible with the established syringe design remain compatible with the CONNECT syringe design. However, the reverse is not applicable. Therefore, during the transition period, until March 2028, there remains an increased risk of inadvertently using an incorrect NFC.

Products Affected:

• Aurum pre-filled syringes are not supplied through NHS Supply Chain.
• Please review the attached product listing and connector compatibility chart for details of the range of compatible needle free connectors (NFCs) for both Aurum Legacy and CONNECT syringes available from us.

Next Steps:

• Please refer to the MHRA’s alert for full details.
• See our Useful Links section to view MHRA’s alert.

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.