BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE, ROLL AROUND INJ SYSTEM

    MDR report key: 12359901 · Received August 24, 2021

    Report

    Report Number
    1518293-2021-00024
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Report Date
    July 27, 2021
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K073592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2021. THE CUSTOMER REPORTED INJECTOR WILL NOT INJECT FULL VOLUME OF GAD FROM GUERBET SYRINGES (10,15,20) APPROX. ONLY 60%. REPORTER STATES THAT PATIENT WAS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260526 ELITE, ROLL AROUND INJ SYSTEM ELITE, ROLL AROUND INJ SYSTEM DXT LIEBEL-FLARSHEIM 814001 C0919D067G

    Patients

    Seq Age Sex Outcome Treatment
    1