It was reported that foreign particulate was noted within the syringe.The foreign particulate was described as "a blue piece of plastic." 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.Testing was performed using returned samples and retained samples of the reported product lot.Four (4) out of five (5) returned samples were observed to have foreign particulate while only one (1) failure was observed with retained samples.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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