A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) review was conducted and no issues related to this complaint were found.Device manufactured on (b)(4) 2008.A document assessment (fmea) was conducted and no changes were required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.At this time since the device is not available it is not possible to determine the source of the defect reported.The customer complaint cannot be confirmed.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend relating complaints.
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