Unique device identification (udi): (b)(4).The surgical patties were returned for evaluation: device history record (dhr) - the lot number for the product was not reported and could not be determined from the returned product.Therefore, a manufacturing record review is not possible.Failure analysis - the pattie/strip unit was inspected using the unaided eye.The complaint report of 9 patties was confirmed.The complaint could be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation confirmed the complaint.However, because this product is made on two different types of machines (automatic or hybrid) it is not possible to determine the root cause since it cannot be determined which machine this specific pattie was made on.If these patties were made on an automatic machine, then the root cause would be the machine not detecting the count being incorrect.If it were made on a hybrid machine, the root cause would be operator error since the operator would have been the one to miss the count of patties.To determine which is the actual root cause, the lot number would need to be known so it could be known which type of machine the product was manufactured.A corrective action is currently open to investigate the patties/strips product family.
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