Qn#(b)(4).The device has not been returned for investigation.A device history review could not be conducted since the lot number and product code was not provided.No corrective action can be implemented due to the lack of product code and batch number to perform a proper investigation to determine a root cause.In conclusion, the customer complaint cannot be confirmed due to the lack of product sample and batch number to perform a proper investigation and determine a root cause.Teleflex will continue to monitor and trend related events.
|