It was reported that a syringe component within the pack was broken.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 the syringe was observed to be broken below the 10ml marking by the wing portion of the component.It is likely the syringe broke due to mishandling at some point during its lifecycle.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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