BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2

    MDR report key: 21945871 · Received May 1, 2025

    Report

    Report Number
    1125230-2025-00016
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Report Date
    April 30, 2025
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). NO SAMPLES WERE PROVIDED FOR EVALUATION. NO BATCH NUMBERS WERE PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THE COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER STATES TUBES ARE UNDERFILLING. STRAIGHT NEEDLES AND BUTTERFLIES ARE USED FOR SPECIMEN DRAWS. IF A SYRINGE IS USED THEN THE TUBE CAN BE FILLED TO OPTIMAL VOLUME. A DISCARD TUBES IS USED IF NEEDED. PHOTOS PROVIDED SHOWED THAT MOST ALL SPECIMENS WERE FILLED TO +/-10% OF THE NOMINAL FILL. TECH SERVICE ADVISED THIS TO CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195296 VACUETTE® TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2 EVACUATED BLOOD COLLECTION TUBES GIM GREINER BIO-ONE NORTH AMERICA, INC 454323 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown