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.
Medical device manufacturer, B. Braun Melsungen AG, has issued a medical device safety alert concerning its Original Perfusor Line [Article Name: PERFUSOR LINE, UV-PROTECT, PE, LL,150CM, PERFUSORLINE, PE, LL, 150 CM; Article Number: 8723017, 8722935; Batch: 22D26E8SC6, 22E10E8SC6, 22E20E8SC6, 22F12E8SC6] [HKMD No.: 160343].
The manufacturer has identified the risk for holes and leakages in the affected products during Post Market Surveillance activities. 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.
The manufacturer is advising users to identify, quarantine and return the affected product.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Jan 2023