BD® CD16 (3G8) PERCP-CY¿5.5

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS INCORRECT LABEL INFORMATION ON THE BD® CD16 (3G8) PERCP-CY¿5.5 . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT MISLABELED CAP. MISLABEL OF CAP ON THE VIAL. 338433_3135741 MISLABELED CAP.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: (B)(4). H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF MISLABEL OF CAP IN THE VIAL OF CD16 PERCP-CY5.5 (ASR) PRODUCT WAS CONFIRMED BASED ON PICTURE PROVIDED BY CUSTOMER, HOWEVER, INSPECTED RETAIN SAMPLES DID NOT REPRODUCE THE DEFECT. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: CUSTOMER PHOTOS SHOWING THE DEFECT. VISUAL INSPECTION OF RETAIN SAMPLES SHOWING CORRECT LABELING. BHR REVIEW SHOWING PRODUCT WAS MANUFACTURE IN COMPLIANCE WITH ESTABLISHED PROCESSES AND PROCEDURES. WHILE THE POTENTIAL CAUSE WAS NOT ESTABLISHED DUE TO THE RETAIN SAMPLES ANALYSIS, THE CUSTOMER WAS PROVIDED WITH A CREDIT TO RESOLVE THE ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS INCORRECT LABEL INFORMATION ON THE BD® CD16 (3G8) PERCP-CY¿5.5 . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT MISLABELED CAP. MISLABEL OF CAP ON THE VIAL. 338433_3135741 MISLABELED CAP.