BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75

    MDR report key: 11016660 · Received December 16, 2020

    Report

    Report Number
    1125230-2020-00077
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    December 15, 2020
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT (B)(4): GBO COULD NOT OBTAIN THE DATE OF THE EVENT. NO SAMPLES OR MORE INFORMATION WERE RECEIVED FOR EVALUATION. THE COMPLAINT IS CLOSED AS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATES TUBES ARE NOT FILLING COMPLETELY TO THE LINE AS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484808 VACUETTE TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454334 B200834H

    Patients

    Seq Age Sex Outcome Treatment
    1