Correction made to f10/h6: health effect - impact codes: replace f26 with f27.H4: lot manufacture date: may 27, 2022- may 28, 2022.H10: the device was received for evaluation.Visual inspection was performed and damaged tubing was observed.The reported condition was verified.Indentation marks from the manufacturing flow wrap sealer equipment were observed on the damaged tubing body which suggested the cause of damage was related to manufacturing.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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