BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11588752 · Received March 30, 2021

    Report

    Report Number
    1125230-2021-00030
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Report Date
    March 30, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT CO21-2100-150: A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. NO SAMPLES WERE RECEIVED FOR EVALUATION. NO PICTURES WERE RECEIVED. WE HAVE NO REMAINING INVENTORY OF 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 TUBES NOT FILLING UP TO THE FILL LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490949 VACUETTE TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454322 B200337H

    Patients

    Seq Age Sex Outcome Treatment
    1