Additional information: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph revealed that the pre-pump pbp line (white) was inverted with the post-pump effluent line (yellow).The reported condition was verified.The cause of the condition was determined to be an operator error during manufacturing.To address this issue, the involved operator has been retrained and awareness training was provided to all operators.The reported lot was manufactured prior to this action.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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