The device was received for evaluation.The returned unit was labeled for singe 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 size of the particulate matter was found to be within specification for this device.The device was found to be 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.
|