Two actual (2) samples were received for evaluation.A visual inspection was performed with naked eye and no issues were noted.Functional testing including leak, clear passage, clamp function testing were performed with no issues noted.Integrity testing was performed between the patient adapter and an in-lab titanium adapter; there was no connection issue or leak observed.The reported condition was not verified on the returned samples.The remaining 2 samples were not received; therefore, a device analysis could not be completed for those 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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