(b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the picture revealed that the pbp and effluent lines were incorrectly assembled on the support plate.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.The involved operator was retrained and awareness training was provided to all operators.The batch involved in this report was manufactured prior to these actions.Should additional relevant information become available, a supplemental report will be submitted.
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