BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX FOLEY 16 FR/10 CC CATHETER

    MDR report key: 3866559 · Received June 3, 2014

    Report

    Report Number
    MW5036465
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INDWELLING FOLEY CATHETER (16 FR) WAS IN THE PROCESS OF BEING DISCONTINUED BY THE RN WHEN SHE NOTED DIFFICULTY WITH DEFLATING THE BALLOON. RN WAS ABLE TO DEFLATE BALLOON BY CREATING A SLIT ON THE SIDE OF THE BALLOON PORT. NO HARM OR INJURY TO THE PT. MFR: PLEASE NOTE THAT WE DO NOT SEND PRODUCTS TO THE MFR, BUT YOU MAY ARRANGE FOR PICK-UP BY CALLING MY NUMBER BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324286 BARDEX FOLEY 16 FR/10 CC CATHETER FOLEY CATHETER KOD BARD MEDICAL DIVISION 0165SI163KW8118

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention