The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the provided pictures showed the stopcock of the drain bag is disconnected from 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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