Device manufactured on february 24, 2022- february 25,2022.The device was received for evaluation.A visual inspection with the naked eye and with magnification was performed which observed a tear/hole near the lower left side/edge in the back side of the eva bag.A functional testing was performed which revealed a leak at the lower left side near edge in the back side of the bag.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.
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