H10: the actual device was not available; however, a photograph of the sample and fourteen (14) retained samples were provided for evaluation.The retention samples were inspected and no abnormalities that could have contributed to the reported condition were identified.The photograph was visually inspected and found that the packaging has an opening on one side, potentially generated when the pattern was detached, since it was not made on the pre-cut.The reported condition was verified.The cause of the condition could not be determined.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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