BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA NEO ANGIOGRAPHIC SYRINGE WITH FILLING SPIKE

    MDR report key: 12952817 · Received December 6, 2021

    Report

    Report Number
    MW5105841
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 2, 2021
    Manufacturer
    GUERBET LLC / LIEBEL-FLARSHEIM COMPANY LLC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PART OF PLUNGER KEPT BREAKING OFF ON POWER INJECTOR SYRINGE. POWER INJECTOR REMOVED FROM USE, SYRINGE TURNED INTO NURSING SUPERVISOR, AND ANOTHER POWER INJECTOR WAS OBTAINED TO USE FOR THE REMAINDER OF CASE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843310 ILLUMENA NEO ANGIOGRAPHIC SYRINGE WITH FILLING SPIKE INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT GUERBET LLC / LIEBEL-FLARSHEIM COMPANY LLC. 20200422

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female