H4: the lot was manufactured between may 18, 2023 - june 1, 2023.H10: the actual device was received for evaluation.A visual inspection was performed, and it was noted that the bladder had ruptured in two pieces.The ruptured bladder was examined for any signs of abnormality, and no signs of abnormality were observed on the external and internal surfaces of the bladder, the rupture line and stressmember.The reported condition was verified.The cause of the reported condition was undetermined; however, may be due to a manufacturing 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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