Trend analysis was conducted to determine whether or not there were historical complaints or recent trends that show issues where packaging dye was rubbing off.There were no identifiable trends when investigated for lots 51206 or 51146.Retained lot testing was next conducted to try and trace the issue, however, none of the retained lots experience issues where the dye would rub off.And experiment was carried out to determine what might cause the packaging to fade or rub off.The end-user reported they stored their syringes in the kitchen.Packaging was tested in an environment of higher temperature, oil, and water to see if packaging would discolor or rub off.The high temperature, oil, and water did not cause any fading, however, alcohol did cause the packaging to fade.The storage location of the device is believed to be the cause the dye rubbing/fading off.
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