Additional information was added to d9, h3, h6 and h10.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.Integrity testing was performed between patient adapter and in-lab titanium adapter; there was no connection issue or leak observed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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