BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIT FC BEADS 7 COLOR CE/IVD

    MDR report key: 16380960 · Received February 15, 2023

    Report

    Report Number
    2916837-2023-00036
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    February 8, 2023
    Report Date
    September 19, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO KIT FC BEADS 7 COLOR CE/IVD, PART 656867 LOT 2154643. ¿ PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON 08 FEB 2023 THAT THE LOT NUMBER WAS MISSING ON A TUBE IN PART 656867 LOT 2154643. THE CUSTOMER DISCOVERED THE PROBLEM AND THE RESULT WAS CUSTOMER DISSATISFACTION. INVESTIGATION SUMMARY: ¿ MANUFACTURING DEFECT TREND: THERE ARE NO QUALITY NOTIFICATIONS (QN-ZM) FOR PART 656867 RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OPENED TO 12 MONTHS BACK) IS FROM 08 FEB 2022 TO 08 FEB 2023. RELATED QN(S): N/A ¿ BATCH HISTORY RECORD (BHR) REVIEW: BHR WAS REVIEWED FOR PART 656867 LOT 2154643 AND COMPONENTS PART 91-0842 LOT 2158396 AND PART 91-0945 LOT 2101892. THE MATERIALS MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. BHR FOR PART 656867 LOT 2154643 INCLUDES MS656867 REV. 06 AND PR003 REV. 24 INDICATING THAT THE KIT INCLUDES IVD POUCHES PART 91-0842 LOT 2158396. BHR FOR PART 91-0842 LOT 2158396 SHOWS THAT APC-CY7 POUCHED TUBES PART 91-0945 LOT 2101892 ARE INCLUDED. BHR FOR PART 91-0945 LOT 2101892 INCLUDES PR169 REV. 03 WITH 14 SAMPLE TUBE LABELS, ALL WITH THE REQUIRED LOT NUMBERS. AN INSPECTION REPORT DATED 30 APRIL 2022 STATES THAT THE PRINT ON TUBE LABELS IS LEGIBLE. ¿ COMPLAINT HISTORY REVIEW: THERE IS 1 COMPLAINT FOR THE REPORTED ISSUE IN PART 656867, IT IS PARENT PR 7154690 (THIS COMPLAINT). DATE RANGE IS FROM 08 FEB 2022 TO 08 FEB 2023. ¿ RETAIN SAMPLE ANALYSIS: THE RETAIN SAMPLE OF KIT PART 656867 LOT 2154643 WAS OBTAINED AND INSPECTED. THE DEFECT WAS NOT PRESENT. ALL 5 TUBES OF APC-CY7 HAD LOT NUMBERS. ¿ RETURNED SAMPLE ANALYSIS: A RETURNED SAMPLE WAS NOT MADE AVAILABLE. RETURN OF THE KIT IS NOT REQUESTED BECAUSE THE COMPLAINT IS CONFIRMED BY PHOTO. THE CUSTOMER PROVIDED 1 PHOTO, SHOWING 1 TUBE LABELED APC-CY7, AND THE SPACE FOR LOT NUMBER IS BLANK. THE APC-CY7 TUBE IS A COMPONENT OF THE KIT PART 656867 LOT 2154643. ¿ LABELING /PACKAGING REVIEW: LABELING / PACKAGING FOR PART 656867 LOT 2154643 WAS REVIEWED. THE MATERIALS MET THE LABELING / PACKAGING SPECIFICATION PRIOR TO RELEASE. ¿ RISK REVIEW: PROCESS FAILURE MODE EFFECTS ANALYSIS (PFMEA), KIT PACKAGING PR003, 10000525149 REV.01 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES HAZARD ID#: NOT NUMBERED HAZARD: LABEL HAS INCOMPLETE OR ILLEGIBLE INFORMATION CAUSE: DIRTY OR WORN PRINT HEAD, PRINTER SETUP HARMFUL EFFECTS: WRONG ASSAY RESULT OR CANNOT RUN ASSAY. DELAY IN TESTING. RESIDUAL SEVERITY: 7 RESIDUAL PROBABILITY: 2 RESIDUAL RISK INDEX: 42 ¿ POTENTIAL CAUSES: BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL CAUSE WAS A PROBLEM IN THE PRINTER. ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE INSPECTION OF RETUNED PHOTOS, INSPECTION OF RETAINED MATERIAL, REVIEW OF COMPLAINT TREND, DEFECT TREND, BHR, AND RISK ANALYSIS, THE COMPLAINT IS CONFIRMED. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULT, COMPLAINT IS CONFIRMED BY PHOTO.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD KIT FC BEADS 7 COLOR CE/IVD THAT THERE WAS A LABELING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THE CUSTOMER'S REPORT IS THAT THE LOT NUMBER WAS MISSING ON THE TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD KIT FC BEADS 7 COLOR CE/IVD THAT THERE WAS A LABELING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S REPORT IS THAT THE LOT NUMBER WAS MISSING ON THE TUBE. A PHOTO IS ATTACHED IN "ATTACHMENT(S)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928009 BD KIT FC BEADS 7 COLOR CE/IVD NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 2154643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown