BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX FOLEY

    MDR report key: 2791987 · Received September 25, 2012

    Report

    Report Number
    2791987
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    August 7, 2012
    Report Date
    September 25, 2012
    Manufacturer
    BARD MEDICAL UROLOGICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REMOVED FOLEY CATHETER USING 10 ML SYRINGE. RN THAT REMOVED CATHETER PULLED ON SYRINGE 3 TIMES TO MAKE SURE ALL SALINE WAS OUT OF BALLOON AFTER THE SYRINGE MANUALLY FILLED. PULLED CATHETER OUT OF PATIENT WITH MUCH DISCOMFORT TO PATIENT AND NO RESISTANCE. RN NOTED BLOOD ON CATHETER AND THAT A SMALL LOOP ON THE BALLOON WAS STILL INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX FOLEY CATHETER, RETENTION TYPE, BALLOON KOD BARD MEDICAL UROLOGICAL 165816 NGWE0716

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR NO OTHER THERAPIES