Initial reporter facility name: (b)(6).The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the provided photos allowed to observe that tape was stuck on the drain bag sealing, which seems to indicate where the leak came from.The reported condition was verified.The cause of the reported 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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