It was reported that the "rubber" of the syringe plunger is sticking.The reporting facility followed up with the manufacturer following their initial report indicating that they determined that they were using the syringe incorrectly.Reportedly, the "sticking" issue was noted when the syringe plunger was being pulled back prior to expelling the air bubble within the pre-filled saline flush.When the reporting facility switched to expelling the air bubble without pulling back on the syringe plunger first, the reported "sticking" did not occur.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 problems/issues.No sample was returned for evaluation and the reported problem/issue was not confirmed.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) 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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