BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFELOCK TRANSPORT BAH 12" X 15"

    MDR report key: 1263864 · Received December 10, 2008

    Report

    Report Number
    1263864
    Event Type
    Malfunction
    Date Received
    December 10, 2008
    Date of Event
    December 9, 2008
    Report Date
    December 10, 2008
    Manufacturer
    COVIDIEN KENDALL
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMALL CHEMO SPILL OCCURRED AT PATIENT'S BEDSIDE WITH DOXORUBICIN. CHEMOTHERAPY BAG HAD BEEN PLACED IN A YELLOW TRANSPORT BAG AND CARRIED OUT TO NURSES STATION TO BE PROPERLY DISCARDED. SEVERAL STEPS OUTSIDE THE ROOM, ANOTHER RN POINTED OUT THAT THE DOXORUBICIN WAS LEAKING THROUGH THE CHEMOTHERAPY BAG AND WAS DRIPPING ALL OVER FLOOR. THE 2 RNS QUICKLY GRABBED A NEW YELLOW BAG OUT OF THE DRAWER AND PUT THE LEAKING BAG INTO THE NEW BAG; HOWEVER, THE CHEMOTHERAPY IMMEDIATELY STARTED LEAKING THROUGH THAT BAG AS WELL. FINALLY, THEY PLACED EVERYTHING IN THE BIG BAG THAT CAME OUT OF THE CHEMO-SPILL KIT WHERE IT APPEARED TO BE CONTAINED. AFTER NOTIFYING ENVIRONMENTAL HEALTH AND SAFETY AND CLEANING THE SPILL PER PROTOCOL, THEY CHECKED OTHER CHEMO BAGS TO SEE IF THEY, TOO, LEAKED. THEY FOUND THAT MOST OF THE STOCK OF BAG LEAKED WATER OUT OF THE BOTTOM CORNER WHEN TESTED. THE BAGS ARE BEING RETURNED TO THE MANUFACTURER. AS SOON AS A LOT NUMBER IS IDENTIFIED, THE STOCK WILL BE CHECKED AND THIS REPORT WILL BE UPDATED.====================== MANUFACTURER RESPONSE FOR DRUG TRANSPORT BAG, CHEMOBLOC * SAFELOCK======================AWAITING AN RA NUMBER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFELOCK TRANSPORT BAH 12" X 15" IV BAG KPE COVIDIEN KENDALL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *