BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 2220434 · Received August 9, 2011

    Report

    Report Number
    2220434
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 9, 2011
    Manufacturer
    C. R. BARD INC
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PT AND RN DISCUSSED A PLAN FOR A VOID TRIAL, INCLUDING A METHOD OF INSTILLING NORMAL SALINE (NS) INTO THE BLADDER. FOLLOWING HANDWASHING AND PREPPING THE BLUE CATHETER TUBING LEUR LOCK PORT, THE TUBING WAS MILKED TO EMPTY THE BLADDER COMPLETELY, THEN THE TUBING WAS CLAMPED. A 60CC WAS INSTILLED INTO THE LEUR LOCK PORT WITH EASE, AND THERE WERE NO COMPLAINTS OF DISCOMFORT. AS THE NEXT 20CC'S WERE BEING INSTILLED WITH EASE, A 'POP' WAS HEARD AND THE VOID TRIAL WAS IMMEDIATLY STOPPED. AS THE PT WAS LEANED BACK, MINIMAL TENSION WAS APPLIED TO THE CATHETER TO STABILIZE IT AND IT SLIPPED OUT OF THE PT EASILY. THE TIP OF THE CATH WAS INTACT, BUT THE BALLOON WAS MISSING. THE PT WAS IN NO APPARENT DISTRESS. THE BLADDER SCANNER SHOWED THAT 700CC'S WERE IN THE BLADDER. THE MD WAS IMMEDIATELY NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD BARD FOLEY TRAY CONTAINING DRAINAGE BAG KOD C. R. BARD INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *