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 the leak at the level of the junction between the lower dialysate port and the filter's shell due to a crack.The reported condition was verified.The cause is related to transportation/shipping issues.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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