H4: the lot was manufactured between july 17, 2023 ¿ july 18, 2023.The device was received for evaluation.Visual inspection was performed, and a rupture in the bladder was observed.Further inspection of the external and internal surfaces of the bladder, rupture line, and stressmember were performed; no signs of abnormality were observed.The reported condition was verified.The cause of the condition could not be determined; however, a possible cause of the bladder rupture may be due to inherent variation in the material from manufacturing, as the bladder 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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