It was reported that a syringe component was noted to have black staining within the barrel.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.The sample was filled with liquid and inside there appeared to be a dark greyest stain or material that appeared to be embedded with the material of the syringe.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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