H4: the lot was manufactured july 13-14, 2023.H10: the actual device was not available; however, a video of the sample was provided for evaluation.Visual inspection of the video showed a leak at the solvent-bonded junction of the tubing and stressmember located near the fill port.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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