It was reported that leakage was noted when drawing up medication into the syringe.Leakage was reportedly observed around the black rubber stopper of the syringe.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.Four (4) samples in new condition were returned for evaluation.Visual and functional testing of all samples was unable to reproduce or confirm the reported problem/issue.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.If additional relevant information becomes available a supplemental medwatch will be filed.
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