The device was received for evaluation.A visual inspection was performed and loose particulate matter (pm) was identified on the inside wall of the inner pouch.The pm was inspected under the microscope and it was determined to be room-temperature-vulcanizing (rtv) silicone; however, the size of the pm was found to be under 0.80 mm squared.This size pm was found to meet specification.The reported condition 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.Should additional relevant information become available, a supplemental report will be submitted.
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