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, Bard Peripheral Vascular, Inc, has issued a medical device safety alert concerning its Catheter Repair Kits [Product Name: 4.2 Fr Broviac CV Catheter Repair Kit, 6.6F Broviac CV Catheter Repair Kit, 9.6F Hickman CV Catheter Repair Kit, Hickman / Leonard CV Catheter Repair Kit (all except 13.5F), 9F Hickman CV Catheter Repair Kit, 12F Hickman CV Catheter Repair Kit, 12.5F Hickman CV Catheter Repair Kit, 10F Leonard CV Catheter Repair Kit, 7F Hickman CV Catheter Repair Kit, 10F Hickman CV Catheter Repair Kit, 7F Groshong CV Catheter Repair Kit, 8F Groshong CV Catheter Repair Kit; Catalog number: 0601610, 0601620, 0601630, 0601680, 0601690, 0601700, 0601710, 0601730, 0601740, 0601750, 0601760, 0601790, 7741700, 7741800; Multiple Lot/Serial Number] [HKMD No.: 090523].
According to the manufacturer, as of 31 Oct 2022, it has received complaints regarding hardened/coagulated adhesive. The manufacturer is investigating and has identified nonconforming products that contain this issue. Hardened or coagulated adhesive has the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained, therefore potentially prolonging surgery or necessitating exchange. The manufacturer is instructing affected users to remove the affected product from use.
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 10 Jan 2023