The customer did not retain the product lot information for this infiniti procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified to determine if it was lint.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 product was manufactured in an environmentally controlled area (eca) that is routinely monitored.In addition, the manufacturing area operates in a controlled positive pressure environment and is continuously monitored to prevent entry of foreign material.No action will be pursued at this time for this occurrence.Complaints are continuously monitored to identify product and/or process areas where debris is occurring.In addition, routine training and awareness is conducted with all manufacturing associates to reinforce the importance of wearing proper ppe and maintaining clean work areas.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).
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