BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75

    MDR report key: 21945870 · Received May 1, 2025

    Report

    Report Number
    1125230-2025-00013
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Report Date
    April 28, 2025
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). NO SAMPLES WERE RECEIVED FOR EVALUATION. NO PICTURES WERE PROVIDED.. WE HAVE NO REMAINING INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. THE COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER STATES THEY EXPERIENCED COLLECTION VOLUME UNDERFILL (DID NOT REACH TO THE FILL LINE; NOT EVEN CLOSE TO 90%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194326 VACUETTE® TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBES, GIM GREINER BIO-ONE NORTH AMERICA, INC 454322 B240633A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown