The single use device was received for evaluation.Visual inspection revealed particulate matter on the outside of the inner pouch.Microscopic inspection revealed that the particulate matter was a fiber.The size of the fiber was analyzed and was found to be within specifications.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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