Investigation results: a single black and white photo was received depicting two heparin medicine vials with needle cannulas sticking out of the vials¿ stoppers.The product was reported to be from batch #7210935 (p/n 309644).One vial was almost empty of liquid and one vial was more than half full of liquid.The cannulas in the photo are by themselves without the needle hubs and syringes.The cannulas are visibly inserted at an angle into the stoppers at approximately 30-45 degrees.A needle which separates from the needle hub is a rejectable condition.However, it appears that the needles were inserted into the vials at a large angle, instead of perpendicular to the stopper, which potentially contributed to the failure.Since no samples were returned and the photo is of poor quality, further investigation is not possible.Based on the available information, the failure cannot be attributed to the manufacturing process.Dhr review for batch 7210935 (p/n 309644): manufacturing dates: 08/04/2017 to 08/05/2017.Batch quantity was 360,000.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7210935 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Bd canaan was not able to duplicate or confirm the customer's indicated failure.Root cause and capa not required based on severity and occurrence level defined for this complaint.
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