It was reported that syringes were received damaged due to open overwrap.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, however, no syringe damage was observed.No physical sample was returned for evaluation.One (1) box of retained samples for each reported product lot was evaluated to determine if any of the syringes from either lots showed open or damaged overwrap.Two (2) syringes from lot 3133549 showed partially torn overwrap near the seal.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.Additional product lot reported = 3133549.
|