BD ALCOHOL SWABS

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. THE CUSTOMER RETURNED TWELVE PHOTOS OF THE ALCOHOL SWAB PACKETS 100 BOX FROM LOT 0056870. THE CUSTOMER REPORTED PACKET BATCH DETAIL UNCLEAR AND INCORRECT LABEL CONTENT. THE PHOTOS WERE EXAMINED. THE EXPIRATION AND MANUFACTURER DATE ARE UNCLEAR MAKING THESE DATES ILLEGIBLE. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0056870. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE NOTIFICATION NOTED FOR ILLEGIBLE PRINT POUCH. BASED ON THE PHOTO(S) PROVIDE EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (PACKAGE PRINTING DEFECT). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT 3 BD ALCOHOL SWABS LABEL INFORMATION ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALCOHOL SWABS PACKET BATCH DETAIL UNCLEAR.