(b)(4).The actual device was not available; however, a photograph of the sample was provided for evaluation.According to the photo a fluid droplet at the header cap is visible, but the cause of the reported failure is not visible.A batch review was conducted and there were no deviations found during the manufacture of this lot.There were (b)(4) dialyzers produced and distributed worldwide from this lot number.Should additional relevant information become available, a supplemental report will be submitted.
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