BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER#174; 9NC 0.109M 2.7 ML

    MDR report key: 21157953 · Received January 15, 2025

    Report

    Report Number
    21157953
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 20, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LIGHT BLUE BD VACUTAINER CITRATE TUBES FOR BLOOD DRAW ARE OVER FILLING. IT SHOULD PULL ONLY 2.7 ML BLOOD INTO THE TUBE, BUT IT IS FILLING THE TUBE UP COMPLETELY. THIS DILUTES THE CITRATE ADDITIVE IN THE BLOOD TUBE CREATING A SAFETY ISSUE. TUBES FROM LOT #S 4157065, 4198287, AND 4222852 ARE ALSO OVERFILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986601 BD VACUTAINER#174; 9NC 0.109M 2.7 ML TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON 363095 4157065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown