BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100

    MDR report key: 11871444 · Received May 24, 2021

    Report

    Report Number
    1125230-2021-00048
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Report Date
    May 24, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT (B)(4). NO SAMPLES WERE RECEIVED FOR EVALUATION. RECEIVED CUSTOMER PICTURES. WE HAVE NO FURTHER 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 · 1

    CUSTOMER STATES "THE BLOOD SAMPLE REMAINS IMPREGNATED ON THE WALLS OF THE TUBE EVEN THOUGH THE SAMPLE IS CENTRIFUGED WITH THE RPM RECOMMENDED BY THE COMMERCIAL COMPANY. CAUSING THE SERUM TO BE VISUALIZED AS "HEMOLYZED" WITHOUT BEING SO. AFFECTING IMMUNOLOGICAL TESTS, AND THE FORMATION OF FIBRIN THAT CLOGS THE EQUIPMENT NEEDLES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770234 VACUETTE TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 455071P B200236F

    Patients

    Seq Age Sex Outcome Treatment
    1