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 Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Bard Peripheral Vascular Inc Trading as CR Bard Inc Mission Kit 16G x 10CM and Mission Kit 18G x 16CM [Lot numbers: 0001445630, 0001449980, 0001447513, 0001448121 and 0001450413; Catalog numbers: 1610MSK and 1816MSK] [HKMD No.: 160421].
According to the TGA, the manufacturer has determined that the Mission Kits from particular lots have a mismatch between the coaxial and the needle in the Mission Kit devices. If the coaxial needle has been deployed, despite incompatibility, unusual adverse events such as needle tip breakage may occur, and an additional device would be required. If a compatible device is not immediately available, the procedure may need to be repeated resulting in minor injury from a new needle puncture and care may be prolonged.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00190-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Mar 2023