H10: the actual sample was received for evaluation.Visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported conditions.All components were correctly placed and according to specifications.Functional testing was performed including priming test, clear passage and pressure testing; and no issues were observed; however, a cut was observed on the tubing.The reported backflow issue could not be verified.The cause of the cut was due to a manufacturing process related issue; a potential root cause was determined as an incorrect tubing placement as part of the coiling operation, leading the packaging machine to cut the tubing.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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