It was reported that the syringe plunger came out of the syringe.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.Testing was performed using the returned sample and retained samples.Testing identified no failures or dislodgement of plungers.The reported problem/issue was unable to be reproduced or confirmed and the root cause was determined to be use error.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.Additional product lot reported = 3135332.
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