Udi - not applicable.Operator of device - unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.The root cause of the complaint could not be identified.We cannot confirm the condition of the actual sample since it was not returned by the customer for our evaluation.Moreover, checking of lot history files and the retention samples showed that no related non-conformities may contribute to the complaint.Our cannula is a supplied raw material that complies with iso 9626, particularly on stiffness and breakage.This was further confirmed when the retention sample did not break after bending it forty times.We have series of visual inspections to check the condition of the product that might lead to the complaint.We also have 2 stages of 100% visual inspection.The first station covers the overall condition of the product.The second station covers the inspection of the catheter tip and needle tip condition and the distance between the catheter tip and needle heel.Thus, defects on the catheter tube such as scratch, hole, crack or partial cut can be detected during these processes.Also, the lot history file was checked and no irregularity or nonconformity was noted that may result in catheter tube breakage.Before shipment, qc also conducts an outgoing inspection to check product quality before shipment.No nonconformity related to the complaint was noted.(b)(4).
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