Device safety informationMHRA
Ethypharm Aurum pre-filled syringes are incompatible safety warning over a safety concern
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.
What to do now
Ethypharm Aurum pre-filled syringes are incompatible is the subject of an MHRA device safety notice.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2023/008). Quoted as issued.
Summary
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.
The risk
Devices Details Device Name: Needle free connectors (NFCs) Manufactured by: Various manufacturers
Advice for healthcare professionals
Actions for healthcare providers
Refer to the list of compatible needle-free connectors (NFCs) for each pre-filled syringe in the Aurum range, which is available under the listing for each pre-filled syringe on the electronic medicines compendium (eMC) website. The lists of compatible NFCs are identical for all Ethypharm Aurum pre-filled syringes. See product information via the links below:
Adrenaline (Epinephrine) Injection 1:10,000 (glass prefilled syringe)
Amiodarone 30mg/ml Solution for injection/infusion in pre-filled syringe
Calcium Chloride Intravenous Infusion, 10% w/v pre-filled syringe
Naloxone Hydrochloride 1mg/ml Solution for Injection in a pre-filled syringe
Procure compatible NFCs for use with the Aurum pre-filled syringes
Ensure that the specification of NFCs which are integral to vascular access devices are checked for compatibility before procuring or putting into use in areas where Aurum pre-filled syringes may be used
Refer to the compatibility warnings and Luer size limits in the instructions for use of the NFC
Train administration and emergency teams to ensure procedures are in place to determine the compatibility of NFCs in use with the Aurum pre-filled syringes contained in emergency drug boxes and on emergency trolleys
Ensure sufficient supply of product in emergency drug boxes and on emergency trolleys to maintain care provision in case of maladministration
Co-locate compatible NFCs with the Aurum pre-filled syringes where it is stored for use (for example, emergency trolleys or kits)
Open the MHRA notice
Questions
Why has Ethypharm Aurum pre-filled syringes are incompatible been recalled?
Ethypharm Aurum pre-filled syringes are incompatible is the subject of an MHRA device safety notice. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.