The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided photo showed the product during treatment, filled with blood.A water drop in the header area was visible.The reported condition was verified.The cause 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.
|