Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning B. Braun Melsungen AG Original Perfusor Line [Product Code: 8255172 - PVC, LL, 50 CM, Product Code: 8255253 - PVC, LL, 300 CM, Product Code: 8722862 - PVC, LL, 200 CM, Product Code: 8722960 - PVC, LL, 150 CM] [HKMD number: 160343].
According to MHRA, the manufacturer was identified that the male Luer connectors of the above-mentioned article batch combinations show dimensional deviations. This could have the effect, that a tight and safe connection to other products is not possible. The deviation might harbour the risk for the patient of microbial contamination, under supply, open patient access, or air infusion. A potential consequence for the healthcare worker is given by contact to hazardous drugs.
For further information, please visit https://mhra-gov.filecamp.com/s/d/UvBME9GDkmmXwaOs
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Feb 2024