(b)(4).A visual nor functional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.The device history record of batch number 74g2000459 that belong to catalog number a-6000-08lf (pe adult-ped dry/ wet lf) has been reviewed and no issues or discrepancies were found which could potentially be related 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.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.However, material from the production line was verified and no issues were found that can lead to this customer complaint.If the sample becomes available this investigation will be updated with the evaluation results.Teleflex will continue to monitor and trend related events.
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