(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 showed that the pbp and effluent lines were incorrectly assembled on the support plate.The reported condition was confirmed.The cause is an error during the manufacturing process.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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