Five (5) samples out of sixteen (16) were received for evaluation.A visual inspection was performed with naked eye with no issues noted.Functional testing including leak testing, clear passage testing and clamp function testing were performed with no issues noted.The reported condition was not verified on the returned samples.Eleven (11) devices were not received for evaluation; therefore, a device analysis could not be completed on 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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