The customer did not retain the product lot information, therefore the device history records traceable to the reported procedure pack could not be reviewed.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.No sample has been received for evaluation; therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be conclusively determined as a sample was not received and the condition of the product could not be verified.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.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate the manufacturer internal reference number is: (b)(4).
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