It was reported that the syringe barrel was cracked and that it leaked its fluid.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.No photo or sample were provided for evaluation.Evaluation of retained samples identified no similar syringe failures.It is believed that low temperatures experienced by the product during shipping and/or at the reporting facility contributed to the observed syringe barrel cracking.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
|