H4: the lot was manufactured from june 23, 2020 - june 24, 2020.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak at the spike port weld in back of the bag.Additional magnified inspection was performed which verified a small tear/hole where the leak occurred.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.
|