It was reported that a syringe component broke during use.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A photo was provided for review and the needle end of the syringe component was observed to had broken off from the body of the component.No sample physical sample was returned for evaluation.Based on the information provided by the reporting facility, the root cause was determined to likely have been caused by the user.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
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