(b)(6).The device was manufactured april 8, 2015 ¿ april 9, 2015.The actual device was not available; however, a photograph of the sample was provided for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection of the photograph revealed that the device¿s bladder was ruptured.The reported condition was verified.The cause of the condition was not determined.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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