1.Dhr/bhr review(lot#3108397): 1)this batch of products were assembled at intima ii auto line 2 in (b)(6) 2023, and packaged at r240 package line in (b)(6) 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 sample and photo have been received for the complaint.3.Check the retained samples of this batch, no foreign matters are found.Please see attachment for the check report.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 regarding this batch of products.Since the specific site, status and composition of the foreign matter in the indwelling needle cannot be identified, the root cause of this defect cannot be determined.The plant will continue to pay attention to and monitor such defects.H3 other text : see narrative.
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