Additional information: h3, h4, h6, h10.H10: the actual device was not available; however, three photographs of the sample and two retained samples were provided for evaluation.The returned photographs were reviewed, and although liquid droplets were present on the outside of the tube, it was not possible to identify the position of the cut/hole from the photographs provided.The reported condition was verified for the photographs of the sample.The cause of the reported condition could not be determined.Visual inspection on the two retention samples did not identify any abnormalities that could have contributed to the reported condition.Functional tests (push-pull test, underwater leak test, air passage test) were performed, and no disconnections were identified, no leaks were identified, and no blockages were found.The retention samples underwent traction testing, and it was confirmed that both samples withstood the minimum required force.The reported condition was not verified on the retained samples.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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