The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection revealed that the pbp and effluent lines are incorrectly assembled on the support plate.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was determined to be a human error during manufacturing.Awareness training has been provided to all operators to address this issue.This lot was manufactured prior to the training.Should additional relevant information become available, a supplemental report will be submitted.
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