Additional information was added to h3, h4, h6 and h10.H4: the lot was manufactured from august 09, 2021 - august 10, 2021.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which observed a leak at the spike port weld in back of the bag.Additional magnified inspection verified a tear/hole where the leak occurred.The reported condition was verified.The cause of the condition could not be determined.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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