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 Administration (TGA) has posted a medical device safety alert concerning Ethicon, Inc. MONOCRYL (poliglecaprone 25) Suture and MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture [HKMD No.: 070016, 070183, 110237, 110238, 210320].
According to the TGA, the manufacturer was identified a manufacturing problem with a specific packaging machine that resulted in a hole in the primary packaging of a small percentage of MONOCRYL and MONOCRYL Plus sutures manufactured between January 27 and March 27, 2024.
The occurrence of this defect is rare with an estimated rate of 0.011% of product presenting the condition.
If the defect is not detected, the breach in sterility could introduce pathogens to the patient and cause infection.
A hole in the cavity also exposes the product to the environment which could potentially compromise its physical properties leading to treatment failure which may require additional surgical intervention or prolonged surgery.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00407-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 May 2024