It was reported that when unpackaging the copilots, it was noted that the copilot pouches had a black line across the label and the pouches were labeled "not for human use." the devices were not used, no patient involvement.There was no clinically significant delay during the procedure.No additional information was provided.
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(b)(4).Evaluation summary: the device was returned for analysis.Visual inspections were performed on the returned device.The labeling issues 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.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear 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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