(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated age and weight.The device was received.A visual, dimensional and functional inspection was performed on the returned device.The reported tip detachment was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to insert, as the reported issue could not be confirmed during return analysis testing; however, the reported tip detachment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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