The device was received for evaluation.Visual inspection identified loose particulate matter on the inside wall of the outer pouch.Microscopic inspection determined that the particulate matter was a fiber.The reported condition was verified; however, the size of the particulate matter was found to be within specification for this 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.
|