BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2250823 · Received August 25, 2011

    Report

    Report Number
    2250823
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT FOLEY CATHETER (10 FR SILICON) WAS BROKEN APART ABOVE THE AREA WHERE YOU PLACE FLUID INTO THE CATHETER TO KEEP IT IN PLACE. THE PT WAS COMBATIVE AND MOVING. I AM NOT SURE IF PT SOMEHOW CAUGHT THE CATHETER WITH THEIR FOOT OR NOT. I AM NOT SURE IF THIS IS A MANUFACTURER ISSUE OR NOT. THE FOLEY WAS DISCONTINUED AND THERE WERE ORDERS TO DISCONTINUE BEFORE THE INCIDENT. DR INSTRUCTED RN TO REMOVE THE CATHETER DURING HER SHIFT. THE REMAINING CATHETER WAS REMOVED FROM THE PENIS AND THERE APPEARED TO BE NO TRAUMA TO THE PENIS. THE TAPE IN PLACE TO SECURE THE FOLEY WORKED NICELY BY KEEPING IT FROM PULLING ON THE PENIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, FOLEY KOD BARD ACCESS SYSTEMS, INC. 1658 NGUJ1132

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DAY