(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided.According to the batch number 74l1700775 provided by the customer the finished good is ip-5041ns.The device history record (dhr) of the product ip-5041ns batch number 74l1700775 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation.Root cause is unknown.If the device sample becomes available this report will be updated.Teleflex will continue to monitor customer feedback for complaints of this nature.
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