It was reported that the syringe had foreign particulate and "a lot of wasted product." no serious injury or adverse impact to a patient or to a user was originally reported.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.One (1) case of product in new condition was returned for evaluation.Visual and function inspection was unable to confirm the reported problem/issue.Tested samples worked as intended and no foreign particulates were identified.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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