Additional information was added to d10, h3, h4 and h6.H10: three (3) actual samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed in all samples including clear passage and pressure testing; and the devices performed according to product specifications.The reported condition was not verified.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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