Initial reporter phone no.(b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection observed particles inside the chamber of the set.The reported condition was verified.The cause of the condition was not determined.A nonconformance has been opened to address this issue.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.
|