The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the provided picture, did not identify any abnormalities as only the label of the dialyzer was visible.As the actual device was not returned, the cause for the reported issue could not be determined.The reported condition was not verified.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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