The actual device was not returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, and retention samples of the involved product/lot number combination.Visual inspection revealed no defects.A review of the lot history files was conducted with no findings.Prior to shipment, qc conducts outgoing visual inspection, sensory inspection and functional testing all samples for the complaint lot passed.The user facility reported a similar event from the same product code/lot number combination.See mdr's 3003902955-2017-00040 and 3003902955-2017-00041.The investigation results verified that the retention sample was the normal product.Without the return of the actual device the exact cause cannot be definitely determined.(b)(4).
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