The actual devices were not available; however, photographs of the samples were provided for evaluation.Visual inspection of the photographs showed the packaging was torn.The reported condition was verified.The cause of the event was due to human error.Refresher training sessions have been conducted, on the positioning of the hard components (roller clamp, slide clamp, etc.) during the coiling method prior the packaging step, to mitigate the risk of such occurrence.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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