The actual device was not available; however, photographs of the sample were provided for evaluation.The returned photographs were inspected and showed evidence that a leak was present from the labeling on the bag.The reported condition was verified.The cause of the reported condition could not be determined.A nonconformance has been opened to address this 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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