Initial reporter facility name: (b)(6).The actual device was not available; however, six (6) retention samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Two (2) retention samples were under water leak tested and no leaks were observed.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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