BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, BALLARD TUBE, GASTRO, MIK KEY SKIN LEVEL

    MDR report key: 2141331 · Received June 14, 2011

    Report

    Report Number
    2141331
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BEARING DOWN AS IF TO STOOL AND THE MIC-KEY BUTTON CAME OUT OF THE PT. UPON RETRIEVING THE BUTTON, THIS NURSE NOTED THAT THE BALLOON FROM THE BUTTON APPEARED TO BE POPPED. THE RN FROM THE TEAM WAS NOTIFIED, WHO INSTRUCTED THIS NURSE TO PAGE THE SURGERY TEAM. THE SURGERY TEAM WAS NOTIFIED, WHO THEN CAME TO THE BEDSIDE TO REPLACE THE BUTTON. THE BUTTON WAS FILLED WITH FIVE ML OF STERILE WATER. AFTER REPLACING THE BUTTON, A KIDNEY, URETER AND BLADDER (KUB) XRAY WITH CONTRAST WAS ORDERED TO CHECK FOR REPLACEMENT. THE PT'S VITALS WERE STABLE THROUGHOUT THE ENTIRE EVENT AND APPEARED TO BE IN NO DISTRESS. IT WAS ALSO REPORTED THAT A COUPLE OF WEEKS AGO, A FLOAT POOL NURSE HAD DONE TEACHING WITH THE PARENTS ABOUT HOW TO REPLACE THE BUTTON IF IT FELL OUT AT HOME. THE FLOAT POOL NURSE PHYSICALLY TOOK OUT THE MIC-KEY AND SHOWED THE PARENTS HOW TO REPLACE IT WITH A NEW ONE. IT IS UNKNOWN TO THIS NURSE IF A KUB WITH CONTRAST WAS EVER ORDERED TO CHECK FOR REPLACEMENT OF THE NEW BUTTON OR HOW MUCH STERILE WATER WAS USED TO FILL THE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, BALLARD TUBE, GASTRO, MIK KEY SKIN LEVEL GT MIC-KEY BUTTON KNT KIMBERLY-CLARK * 0120-14-1.0

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO