BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 BLUECAP-BLACKRING

    MDR report key: 10431553 · Received August 20, 2020

    Report

    Report Number
    8020040-2020-00004
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Report Date
    August 20, 2020
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT (B)(4). WE HAVE NOT RECEIVED SAMPLES OR PHOTOGRAPHS FOR INVESTIGATION FROM THE CUSTOMER. WE HAVE NO FURTHER INVENTORY FOR THIS MATERIAL/BATCH. NO FINDINGS AVAILABLE AS SAMPLES WERE NOT RETURNED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE EXPERIENCING VACUUM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899540 VACUETTE TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 BLUECAP-BLACKRING TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT GIM GREINER BIO-ONE GMBH 454334 A2002366

    Patients

    Seq Age Sex Outcome Treatment
    1