The lot complaint history was reviewed, this is the fifth complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.Images of only the cassette with the drain bag attached was provided.We could not ascertain the failure mode of the consumable device based on the images provided.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.It was noted the customer indicated the images would be sent and the sample would be discarded.The root cause of the customer's event could not be conclusively determined with the information available (images provided).Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.(b)(4).
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