H10: the actual device was discarded; therefore, a device analysis could not be completed for that sample.However, retention samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The retention samples were gravity and leak tested with no issues or leaks observed.The reported condition was not verified on the retention samples.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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