The device was received for evaluation.The returned unit was labeled for single use.Visual inspection revealed particulate matter on the outside wall of the inner pouch.Microscopic inspection revealed that the particulate matter was a fiber.The reported condition was verified.The cause of the condition was not determined.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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