(b)(6).The actual devices were not available; however, six (6) retained samples were evaluated.Visual inspection was performed in all samples using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.A functional testing was completed on two (2) samples and 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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