(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual inspection was performed.The reported foreign material in the packaging was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.The investigation determined the foreign material inside the unopened pouch appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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