(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis and abbott vascular (av) confirmed the reported crack in the hub and subsequent leak when the device was pressurized.A review of the complaint handling database found no similar incidents from this lot.Av reviewed the lot history record and there were no manufacturing nonconformities.Av conducted root cause analysis and determined the issue may be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.
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