H4: the lot was manufactured between june 12, 2023 ¿ june 13, 2023.H10: the device was received for evaluation.During visual inspection, the bladder was observed ruptured.The reported condition was verified.The external and internal surfaces of the bladder and the rupture line were microscopically examined for evidence of markings, abrasions, gouges, holes, or embedded particulate matter along with any surface defects on the stress-member for any signs of abnormality which may have caused the device to rupture.No signs of abnormality were found on the ruptured bladder.The cause of the condition could not be determined, however, the potential for bladder ruptures exists as bladders are manufactured with rubber.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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