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. Mission Disposable Core Biopsy Instrument and Kit [Catalogue numbers: 1410MSK, 1416MSK, 1610MSK, 1616MSK, 1810MSK, 1816MSK, 1820MSK, 1825MSK, 2010MSK, 2016MSK, 2020MSK; Multiple lot numbers] [HKMD No.: 160421].
According to the TGA, the manufacturer has determined that the specific Mission Kits have a mismatch between the coaxial and the needle in the Mission Kit devices. Device incompatibility is due to a needle where the external diameter of the needle of the device is allegedly larger, longer or smaller than the internal diameter of the Disposable Coaxial Biopsy Needle, which would not allow for the needle of the device to be inserted into the coaxial.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00981-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Nov 2023