(b)(4).A visual nor functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record of batch number 74g2000459 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to our specifications.No corrective action can be established at this moment since the product sample is not available for evaluation.Product sample is necessary to perform a proper investigation to determine the root cause and the corresponding corrective actions.The root cause is undetermined-no sample.The customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.Functional test process of current production of a-6000-08lf was reviewed and no issues were observed that can lead to the defect reported.If the defective sample becomes available at later date this complaint will be updated as applicable.Teleflex will continue to monitor and trend related events.
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