BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4F PEDIATRIC PIGTAIL CATHETER

    MDR report key: 3850486 · Received May 29, 2014

    Report

    Report Number
    3850486
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MERIT MEDICAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    CATHETER WOULD NOT ACCEPT A 0.035 GUIDEWIRE DURING A CARDIAC CATH PROCEDURE. ANOTHER CATHETER WAS OPENED AND WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316784 4F PEDIATRIC PIGTAIL CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL, INC. PED-PIG-VSC-2B E551382

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR