H4: the lot was manufactured from august 16, 2021 - august 17, 2021.H10: six (6) actual samples were received for evaluation containing 80ml of fluid in their bladders.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.After the luer cap was removed and the slide clamp was disengaged from the tubing in all samples, evidence of continuous flow was visually observed at the distal luer.A functional flow rate test was performed on each sample and the flow rate was found to be within the product specification range.The reported condition was not verified in all samples.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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