It was reported that the "piston rod broke during use" and "a minimal puncture wound occurred".To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, or follow-up care associated with the reported problem/issue.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 for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
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