Additional information was added to h3, h4 and h6.H4: the lot was manufactured from july 06, 2020 - july 07, 2020.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph was performed which identified residual fluid contained inside the device bladder which suggests an underinfusion may have occurred.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause is user related.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.
|