Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: dhr review for batch 7093543 (p/n 305060): manufacturing dates: 4/13/2017 ¿ 4/15/2017.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Preventive maintenance (pm) was performed on the marker during the manufacture of this batch.Scale placement was verified after pm.Batch 7093543 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Sample evaluation: one photo was received by bd canaan.Two 3 ml syringes in their original sealed blister packs could be seen on the photo.One syringe had no scale markings whatsoever, while the second syringe had proper graduated markings.The product with no markings was confirmed to be from batch 7093543 (p/n 305060).Based on the sample evaluation: confirmed: bd canaan was able to confirm the customer's indicated failure.Root cause: failure to discard during marker machine setup or startup.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Based on the severity assigned to this complaint and the results of the complaint lot history check, capa is not required at this time.(b)(4).
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