Additional information was received for d4: expiration date, h3, h4, h6, and h10.H4: device manufacture date: the lot was manufactured from april 3, 2023 to april 5, 2023.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photograph showed the device missing the fill port cap.The reported condition was verified.The cause of the condition could not be 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.
|