H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was a cut in the sterile packaging.The reported condition was verified.Based on the cut pattern on the sample, the cause of the reported condition was determined to be the sterile packaging was cut by the blades during the packaging cut operation of the manufacturing process.This issue occurs if the bottom of the packaging is not placed properly in the cutting machine.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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