BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 18022939 · Received October 27, 2023

    Report

    Report Number
    1917413-2023-01101
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    October 18, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630801
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING SHELF PACK LABEL WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE MISSING SHELF PACK LABEL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    H.3. 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 BEFORE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES THERE WAS NO LABEL OR MISSING LABEL INFORMATON. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: WHILE DOING LABELLING, WE FOUND 1 BOX OF 363080 (LOT NO. 3222676 EXP. 29.02.2024) WITHOUT BD LABEL

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES THERE WAS NO LABEL OR MISSING LABEL INFORMATON. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: WHILE DOING LABELLING, WE FOUND 1 BOX OF 363080 (LOT NO. 3222676 EXP. 29.02.2024) WITHOUT BD LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139085 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3222676 50382903630801

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown