It was reported that foreign particulate was noted within the syringe.According to the reporting facility, no patient was involved in the incident.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 reported problem/issue was confirmed.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on (b)(6) 2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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