(b)(6).The actual device was not available; however, photographs and a video of the sample was provided for evaluation.A visual inspection of the returned photographs and video was performed and it was noted that the pbp and effluent lines were incorrectly assembled on the support plate.The reported condition was verified.The cause of the reported condition was an assembly issue during manufacturing.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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