BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION TUBES

    MDR report key: 11144148 · Received January 9, 2021

    Report

    Report Number
    1125230-2018-00017
    Event Type
    Malfunction
    Date Received
    January 9, 2021
    Report Date
    January 9, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K983952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT CO20-2100-507: NO SAMPLES WERE PROVIDED BY THE CUSTOMER. NO DATA WAS PROVIDED BY THE CUSTOMER. NO MATERIAL NUMBER WAS PROVIDED BY THE CUSTOMER. NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THE COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE SEEING HIGH POTASSIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40009 VACUETTE BLOOD COLLECTION TUBES EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1