The actual device was not available for evaluation, however, eight retained samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The samples were leak tested under water.No abnormalities were identified that could have contributed to the reported condition.A device history review revealed no issues that could have caused or contributed to the reported issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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