The device was received for evaluation.A visual inspection was performed and no abnormalities were observed related to non-conforming product.An embedded particulate matter (pm) was observed on the welded cassette; no loose pm was observed in the cassette.The embedded pm was measured and found to be within product specifications, therefore considered acceptable.Underwater pressure test was performed with no issues noted.The reported condition of pm was not verified related to non-conforming product.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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