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May 26, 2023

Ethypharm Aurum pre

Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs

Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-filled syringes from the Aurum range.

Device Name: Needle free connectors (NFCs)

Manufactured by: Various manufacturers

Devices Name: Aurum pre-filled syringes

Manufactured by: Macarthys Laboratories (Trading as Martindale Pharma, an Ethypharm Group Company,Marketing authorisation holder: Aurum Pharmaceuticals Ltd)

Incompatibility between some NFCs and Luer tips of the Aurum range pre-filled syringes can lead to delayed delivery of medication. The MHRA issued a Medical Device Alert in June 2011 to raise awareness of this safety issue.

The MHRA continues to receive reports of damage to the NFC and/or to the Aurum pre-filled syringe where incompatible devices were connected. In some cases, fragments from the NFC broke off and blocked the syringe outflow. Such damage has resulted in a delay in administering emergency medication.

Healthcare professionals are requested to ensure that only compatible NFCs are used with the Aurum pre-filled syringes.

There are specific reporting arrangements for healthcare professionals to follow in each of the devolved administrations. Healthcare professionals should report incidents:

Aurum connector compatibility chart

National Infusion and Vascular Access Society (NIVAS)

NHS England National Patient Safety Team

NHS Wales

NHS National Services Scotland, Incident Reporting and Investigation Centre (IRIC)

Northern Ireland Adverse Incident Centre (NIAIC)

Health and Social Care, Northern Ireland

Ethypharm Aurum pre-filled syringes are incompatible with some manufactured needle-free connectors: risk of delay in administering potentially lifesaving medication, DSI/2023/008