H10.Additional manufacturer narrative: any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.In this case, it was reported that the box was opened and the cracked jar was found to be leaking fluid.The device was returned for evaluation and the customer report of glutaraldehyde solution leakage and cracked jar was confirmed.As received, shelf box and paperwork were completely soaked.Patch jar was still sealed within its shrink wrapping when received.As received, the patch jar had multiple cracks on the bottom of the jar with one crack extended on the side of the jar.Measurements were taken of each crack: crack a was approximately 7.50" long; crack b was approximately 0.40" long; crack c was approximately 0.70" long; crack d was approximately 0.55" long.Crack a extended along the side of the jar with patch partly extended out.The patch remained inside the jar with a small amount of glutaraldehyde solution left inside.The patch had a few creases, which was likely due to the patch being folded in the jar and not being fully submerged in solution.Damage to the package/product is most likely the result of mechanical damage incurred while in the care of the customer or in transit from the courier, and not an indication of a device malfunction.There as no allegation of a device malfunction and there is no device failure.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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