It was reported that a syringe component was cracked.Reportedly, the crack was identified as a physician as flushing a sheath with the syringe.The syringe was filled with saline and blood at the time of the incident and the physician was sprayed with the fluid.The physician was wearing ppe and he changed/replaced his scrubs and soiled ppe and then washed in a sink.No diagnostic exams or post-exposure treatment was reported.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 photo was provided for review and the syringe in the photo was observed to have cracked from just above the 1ml line to the 9ml line.No physical sample was returned for evaluation.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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