Qn#(b)(4).The device is reportedly unavailable for investigation.A device history review could not be conducted since the lot number was not provided.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample not being available it is not possible to determine the source of the defect reported, the customer complaint cannot be confirmed, and the root cause cannot be determined.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.
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