The actual device was not available; however, photographs of the sample were provided for evaluation.During visual inspection of the photos, a crack in the dialyzer housing was observed in the area under the product label.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the crack was determined to be related to shock applied to the product during shipping, transport, and/or improper storage.Should additional relevant information become available, a supplemental report will be submitted.
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