Two devices were received for evaluation.The received units had been removed from the package but had not been used as evidenced by the presence of the paper tape on the unit, the presence of all protective caps, and the lack of any fluid in the disposable units.The care giver indicated that the units had slices after removal from the packaging which were noticed during setup.Most units were marked in multiple locations with a black marker by the cg where the reported damage appeared to be present.A visual inspection was performed with naked eye and 10x magnification which noted minor indentations and scratches, but no cuts or slices.Functional testing, including leak testing, clear passage testing and clamp function testing, was performed with no issues noted.The reported problem was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported problem was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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