(b)(6).The actual device was not available; however, photographs and a video were provided for evaluation.The returned photographic and video samples were reviewed, and it was noted that there was leakage from the filter blood header.The reported condition was verified.The cause of the reported 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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