It was reported that the syringe plunger was "too loose" and it "refluxes back up the iv line." reportedly, this "blew the plunger out" which resulted in propofol medication leaking.No serious injury or adverse impact to patient or 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.Four (4) boxes of product in new condition was returned for evaluation.Visual and functional testing was unable to reproduce or confirm the reported problem/issue.All tested syringe samples worked as intended.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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