It was reported that foreign particulate was noted within the syringe.The reporting facility originally reported that the problem/issue was identified prior to using the device on a patient.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 and foreign particulate, appearing to be a small burned plastic piece, was observed within the syringe.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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