People who use steel cannula infusion sets manufactured by Unomedical are being asked to check them before and after use as there is a small risk of its needle breaking.
It is important that the infusion set is not used if the needle is bent or has become damaged. This could lead to leakage of the medication. In some cases, this may require surgical intervention to remove the needle.
The needles are part of infusion sets which are used in hospitals and by people at home for the infusion of medicine through an external pump.
They are primarily used by patients with diabetes, Parkinson’s disease and for the treatment of chronic pain.
The following steel cannula infusion sets are affected:
- SURE-T Paradigm
- Contact Detach
- Sub Q
- Neria Detach
- Neria Multi
MHRA is requesting users to check the specific lot numbers of infusion sets prior to and after use and to follow our advice contained within the medical device alert. A healthcare provider should be contacted if a needle has broken off in-situ as medical attention may be required.
Dr Neil McGuire, Clinical Director at MHRA, said:
“This is a precautionary measure and the risk of the needle breaking is low.
“There are millions of these needles in use and we have had only a very small number of reports of them breaking.
“The manufacturer improved the design of the device over a year ago but we advise anyone who has had this problem or who is concerned to contact their specialist nurse or GP.”
- Medical device alert: Steel cannula infusion sets - risk of needle breaking in use
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes NIBSC and CPRD. The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health.