(b)(4).(b)(6).The dialyzer was discarded and not available for technical investigation; however, a video was provided for evaluation.According to the video an external fluid leakage at the connection of the header/housing was visible.The cause of the condition could not be determined.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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