(b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided pictures shows that the pbp and effluent lines were incorrectly assembled on the support plate.The reported condition was verified.Actions have been put in place in the manufacturing lines in order to avoid this defect.The involved lot was manufactured before these actions.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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