BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, CATHETER, FOLEY

    MDR report key: 6692704 · Received July 7, 2017

    Report

    Report Number
    6692704
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    June 11, 2017
    Report Date
    June 15, 2017
    Manufacturer
    C.R. BARD
    Product Code
    NWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOLE NOTED IN BACK OF FOLEY BAG WHERE THE CIRCLE INDENTS ARE LOCATED. THE SPINE WAS BENT AND INSIDE OF THE "RACETRACK". THE BAG WAS CHANGED, BUT UNABLE TO CHANGE CATHETER AS THEY WERE DOING A VENTRICULOSTOMY CLAMP TRIAL AND ICP'S DID NOT ALLOW FOR A CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474055 KIT, CATHETER, FOLEY NWR C.R. BARD

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other