It was reported that the black rubber piece of the syringe plunger detached.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 and the detached black rubber piece was observed to be wedged sideways in the barrel of the piston irrigation syringe.No physical sample was returned for evaluation.The reported problem/issue was confirmed, however, a definitive root cause was unable to be determined.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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