Additional information was added to h3, h4 and h6.H10: the actual devices were not received for evaluation; therefore, a device analysis could not be completed for those samples.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 noted.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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