H4: the device was manufactured june 17, 2021 - june 18, 2021.H10: the device was received for evaluation containing an unspecified amount of fluid in the bladder.Visual inspection was performed using the naked eye which observed a small segment of the tubing was damaged.The reported condition was verified.The cause of the condition was due to manufacturing related issue.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.
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