It was reported that the black piece of the syringe plunger "wears out after one use." according to the user, it then "becomes very hard to push and pull anything up in the syringe." 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 sample was returned for evaluation and a root cause was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on (b)(6) 2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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