(b)(6).The actual device was not available; however, a three (3) retention samples were provided for evaluation.Visual inspection was performed and no issues noted.Functional testing, including under water leak testing, was performed and no issues noted.The reported condition was not verified.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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