Additional information: d4, d9, h3, h4, h6, h10 h4: the lot was manufactured between august 31, 2022 - september 1, 2022 h10: two (2) devices were received for evaluation containing fluid in their bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The bag that contained the units was dry.The outer and inner surfaces of the units were dry.The blue winged cap was observed to be securely tightened without evidence of wetness or leak.A functional leak test was performed by manually adding green color water to the bladder.During fill, no evidence of leak was observed.After fill, the units were being monitored until the next day.The next day, no evidence of a leak was observed.The reported condition was not verified.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.
|