BD FACS LYSING SOLUTION

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT INCORRECT LABEL INFORMATION WAS FOUND ON THE BD FACS LYSING SOLUTION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LABELING ISSUE (B)(4) FACSLYSING, CFDA CLASS I REGISTRATION AND CHINESE PRODUCT MANUAL SHOWS AS FORMALDEHYDE LESS THAN 10%. HOWEVER, CURRENT BOTTLE OUTSIDE LABEL WAS OUTDATED AND MISTAKEN, SHOWING FORMALDEHYDE LESS THAN 15%. IT SEEMS THE LABELS WERE NOT UPDATED AFTER CFDA CLASS I REGISTRATION AND PRODUCT MANUAL UPDATED IN EARLY 2019. AND CUSTOMERS ARE WORRIED ABOUT THE QUALITY AND FUNCTIONALITY.

Description of Event or Problem

IT WAS REPORTED THAT INCORRECT LABEL INFORMATION WAS FOUND ON THE BD FACS LYSING SOLUTION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LABELING ISSUE. 349202 FACSLYSING, CFDA CLASS I REGISTRATION AND CHINESE PRODUCT MANUAL SHOWS AS FORMALDEHYDE LESS THAN 10%. HOWEVER, CURRENT BOTTLE OUTSIDE LABEL WAS OUTDATED AND MISTAKEN, SHOWING FORMALDEHYDE LESS THAN 15%. IT SEEMS THE LABELS WERE NOT UPDATED AFTER CFDA CLASS I REGISTRATION AND PRODUCT MANUAL UPDATED IN EARLY 2019. AND CUSTOMERS ARE WORRIED ABOUT THE QUALITY AND FUNCTIONALITY.

Additional Manufacturer Narrative

H.6. INVESTIGATION: PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON (B)(6) 2020. SCOPE. THE SCOPE OF ISSUE IS LIMITED TO PART 349202. MANUFACTURING DEFECT TREND: THERE ARE NO OTHER QNS RELATED TO THE REPORTED ISSUE FOR THE DATE RANGE BETWEEN 17DEC2019 AND 17DEC2020. COMPLAINT TREND: THERE ARE NO COMPLAINTS BESIDES THIS COMPLAINT RELATED TO THE REPORTED ISSUE FROM DATE 17DEC2019 TO 17DEC2020. BATCH HISTORY RECORD (BHR) REVIEW: BHR FOR 349202-0031304 WAS REVIEWED AND FOUND TO BE LABELED APPROPRIATELY. THIS REPORT REFERS TO LABELING CONTENT. RETAIN SAMPLE EVALUATION / TESTING: THE RETAIN SAMPLE PART AND LOT WAS VISUALLY INSPECTED AND FOUND TO BE LABELED PROPERLY. RETURNED SAMPLE EVALUATION: THE SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE THE REPORTED ISSUE IS AN ISSUE OF LABELING CONTENT. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, BHR, ROOT CAUSE AND RISK ANALYSIS, THE REPORTED COMPLAINT WAS UNCONFIRMED. THERE HAVE BEEN NO CHANGES TO THE COMPOSITION OF FACS LYSING SOLUTION M/N 349202. RISK ANALYSIS: THERE HAVE BEEN NO NON-CONFORMITIES IN 349202-0031304 OR CHANGES TO THE COMPOSITION OF FACS LYSING SOLUTION M/N 349202. THESE IS NO RISK REPRESENTED BY THE REVISION OF THE LABEL; BOTH REVISIONS OF THE LABELED FORMALDEHYDE CONCENTRATION ARE CORRECT. ROOT CAUSE ANALYSIS: BASED ON THE INVESTIGATION RESULT, ROOT CAUSE WAS NOT DETERMINED. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION RESULT, COMPLAINT WAS NOT CONFIRMED.