Additional information: the actual device was not available; however, a four (4) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The device was primed and functionally tested, and the clearlink performed according to product specifications.The reported condition was not verified.The remaining devices were not received for evaluation; therefore, a device analysis could not be completed.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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