Qn#(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record investigation did not show issues related to complaint.A document assessment was conducted and no changes were required.A capa# (b)(4) has been opened by the manufacturing site to address similar issues with the product.Customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend on similar complaints.
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