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 PERFUSOR LINE [PVC, LL, 300 CM] [Article Number: 8255253; Batch Number: 23D10E8SM3, 23D14E8SM3] [HKMD No.: 160343].
According to the MHRA, the manufacturer identified the risk that luer connectors may detach from the Perfusor Line during the regular post market surveillance activities. The deviation might harbour the risk to the patient of microbial contamination, infusion under delivery, an open patient access system, or air infusion. A potential consequence for the healthcare worker is exposure and contact to hazardous drugs.
For further information, please visit https://mhra-gov.filecamp.com/s/d/y7M8G09lwVtbWGgR
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 Sep 2023