Trackwise (b)(4).Updated section: a2, a3, g4, g7, h2, h3, h6, h10.The device was returned to the factory for evaluation on 03/01/2021.An investigation was conducted on 03/29/2021.A visual inspection was conducted.The harvesting device as well as the cannula and the btt was returned.Signs of clinical use and evidence of blood was observed on the harvesting device, the cannula as well as on the btt.There were no visual defects observed on the btt.A mechanical evaluation was conducted.The btt was able to be inflated.No visual defects were observed on the silicone btt.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.Based on the condition of the device, the reported failure "no flow" was not confirmed.The lot # 25153416 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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