BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 2.5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X75

    MDR report key: 11140158 · Received January 8, 2021

    Report

    Report Number
    1125230-2019-00019
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    January 8, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K983952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT CO20-2100-441: NO SAMPLES WERE RECEIVED FOR EVALUATION. NO PICTURES WERE RECEIVED. WE HAVE NO REMAINING INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THE MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE DOCUMENTS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED EVENT. THE COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATES BLOOD WAS HEMOLYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33929 VACUETTE TUBE 2.5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X75 EVACUATED BLOOD COLLECTION TYPE JKA GREINER BIO-ONE NA INC. 454243P B19013XT

    Patients

    Seq Age Sex Outcome Treatment
    1