Additional information: h3, h4, and h6.H10: the actual device was not available; however, fourteen (14) retained samples and four (4) photographs of the samples were provided for evaluation.A visual inspection was performed and noted some openings on the periphery of the package.The pre-cut that separates each package was also observed.The reported condition was verified.The cause of the event was determined to be due to mishandling during distribution.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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