It was reported that the syringe component within the surgical pack is broken.Reportedly, the plunger and barrel flanges were found were found to be broken.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 sample was returned for evaluation.Both the barrel flange and part of the plunger button were broken off and missing from returned sample.The reported problem/issue was confirmed, however, a root cause was unable to be determined.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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