Initial reporter phone no.: (b)(6).Facility name: (b)(6) hospital.The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection observed an external fluid leak from the connection of the filter dialysate port with the support plate.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.
|