H4: the lot was manufactured june 13, 2023 to june 15, 2023.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that that a segment on the tube set had been damaged.There were also indention marks in the damaged area made from the manufacturing flow wrap sealer equipment.The reported condition was verified.The cause of the reported condition was a manufacturing issue.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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