BEUDAMED
    FDA Adverse Event Summary report: N

    KLEENSPEC

    MDR report key: 1559326 · Received December 9, 2009

    Report

    Report Number
    1559326
    Date Received
    December 9, 2009
    Date of Event
    November 11, 2009
    Report Date
    December 9, 2009
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    FTF
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE ATTEMPTED TO START A PERIPHERAL INTRAVENOUS CATHETER USING A TRANSILLUMINATOR FOR ASSISTANCE LOCATING A VEIN. INSTEAD OF THE TRANSILLUMINATOR, HE MISTAKENLY USED A VAGINAL ILLUMINATOR, WHICH CAUSED THE PATIENT TO RECEIVE 2ND DEGREE BURNS ON THE PALM AND ON THE FOREARM. THE VAGINAL ILLUMINATOR LOOKS SIGNIFICANTLY SIMILAR TO THE TRANSILLUMINATOR AND IT HAD BEEN PLACED IN THE SAME AREA WHERE THE TRANSILLUMINATOR WAS KEPT. ALTHOUGH THE NURSE RECOGNIZED IT DID NOT LOOK EXACTLY THE SAME, HE KNEW THAT THERE WERE PLANS TO PURCHASE NEW TRANSILLUMINATORS RECENTLY AND MISTAKENLY ASSUMED THE VAGINAL ILLUMINATOR WAS ONE OF THE NEW ONES. IT WAS NOT.THESE TWO PIECES OF EQUIPMENT ARE NEVER STORED TOGETHER AND WE DO NOT KNOW HOW IT GOT WHERE IT WAS. WE HOPE TO GET TO THE ROOT CAUSE OF THAT, AS WELL AS FORMULATE ACTION PLANS SO THAT THIS DOES NOT HAPPEN AGAIN.

    Description of Event or Problem · 1

    NURSE ATTEMPTED TO START A PERIPHERAL INTRAVENOUS CATHETER USING A TRANSILLUMINATOR FOR ASSISTANCE LOCATING A VEIN. INSTEAD OF THE TRANSILLUMINATOR, HE MISTAKENLY USED A VAGINAL ILLUMINATOR, WHICH CAUSED THE PATIENT TO RECEIVE 2ND DEGREE BURNS ON THE PALM AND ON THE FOREARM. THE VAGINAL ILLUMINATOR LOOKS SIGNIFICANTLY SIMILAR TO THE TRANSILLUMINATOR AND IT HAD BEEN PLACED IN THE SAME AREA WHERE THE TRANSILLUMINATOR WAS KEPT. ALTHOUGH THE NURSE RECOGNIZED IT DID NOT LOOK EXACTLY THE SAME, HE KNEW THAT THERE WERE PLANS TO PURCHASE NEW TRANSILLUMINATORS RECENTLY AND MISTAKENLY ASSUMED THE VAGINAL ILLUMINATOR WAS ONE OF THE NEW ONES. IT WAS NOT.THESE TWO PIECES OF EQUIPMENT ARE NEVER STORED TOGETHER AND WE DO NOT KNOW HOW IT GOT WHERE IT WAS. WE HOPE TO GET TO THE ROOT CAUSE OF THAT, AS WELL AS FORMULATE ACTION PLANS SO THAT THIS DOES NOT HAPPEN AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEENSPEC ILLUMINATOR, VAGINAL FTF WELCH ALLYN, INC. 78810 *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA NO OTHER THERAPIES| NO OTHER THERAPIES