1.Dhr/bhr review(lot#3108396): 1)this batch of products were assembled at intima ii auto line 2 in june 2023, and packaged at r240 package line in june 2023.Work order quantity was (b)(4) ea.2)review the in-process test reports and outgoing test reports, and all test results meet the product specifications.3)review the production records with no nonconformance, deviation or rework activities.2.No defective samples and photos have been received for the complaint.3.Check the retained samples of this batch, no black foreign matter is found at the needle site.Please see attachment for the photo.4.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained samples, and no similar complaints have been received from other hospitals about this batch of products.Since the status and composition of the foreign matter at the needle site cannot be confirmed, the root cause of this defect cannot be determined.The plant will continue to track and monitor such defects.
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