Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: (b)(6) manufacturing.Investigation summary: it was reported there was discoloration on a package.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows packaging blister top webs with part of the graphics with light printing.No other defects or imperfections were observed.This defect could occur if the printer equipment had low ink inducing the symptom reported.A device history record review was completed for provided material number 305201, lot number 1273791.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the top web printing process was performed.The settings, alignment and printing graphics were all acceptable.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.
|