(b)(6).The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the provided pictures showed that there was an external leak at the level of the drain bag sealing, near the stopcock.The reported condition is confirmed.The cause of the condition could not be determined.This issue is being further investigated.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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