The device was received for evaluation and the evaluation was completed.A visual inspection was performed on the returned device via the naked eye and no issues were noted.Leak testing, clear passage testing, and clamp function testing were performed and the reported problem was not duplicated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was not verified and the device met all product specifications.Should additional relevant information become available, a supplemental report will be submitted.
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