(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation.A visual inspection revealed that the roller clamp was in the closed position.However, it is not clear if the roller clamp was closed during the reported event.The visual inspection did not reveal any kinks which might have also inhibited the flow.No further analysis could be performed because the set was contaminated with blood.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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