It was reported that the tip of the syringe was "blackened" and that its plunger was "deformed.".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.Investigation into the reported problem/issue was performed using returned and retained samples.Although the reported problem/issue was confirmed with returned samples, inspection of retention samples identified no similar failures.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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