(b)(4).The device was received and the evaluation was completed to investigate the reported issue.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Underwater leak testing was performed, passing successfully with no issues noted.The reported condition could not be verified through evaluation.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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