Initial reporter facility name: (b)(6).The actual device was not available; however, a photograph and a video of the sample were provided for evaluation.Visual inspection identified an external leak fluid from the drain bag due to a hole in the bag.The reported condition was verified.The cause of the condition was determined to be 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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