Trackwise#: (b)(4).The lot # 25161054 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.The device was returned to the factory for evaluation on 05/16/2022.An investigation was conducted on 05/24/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed 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 failures "improper flow or infusion" was not confirmed.
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