H4: the device manufacture date was june 23, 2020 to june 24, 2020.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing was performed, and it was noted that there was leak at the spike port weld in the back of the bag.A magnified visual inspection was performed, and it was noted that there was tear/hole at the back-side spike port weld of the bag.The reported condition was verified.The cause of the reported 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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