BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOTHERAPY 9CYTOXIC DRUGO SPILL CLEAN UP KIT-SAFETEC OF AM

    MDR report key: 185531 · Received September 4, 1998

    Report

    Report Number
    185531
    Event Type
    Malfunction
    Date Received
    September 4, 1998
    Date of Event
    August 26, 1998
    Report Date
    August 28, 1998
    Manufacturer
    SAFETEC OF AMERICA, INC.
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED METHOTREXATE INJECTIONS INTRAMUSCULAR ONCE A WEEK TO TREAT HER ARTHRITIS. THE NURSE ADMINISTERED THE INJECTION OF METHOTREXATE ON 8/26/1998 USING A TUBERCULINE SYRINGE AND A 23 G. 1" NEEDLE. SHE PROCEEDED TO REMOVE THE SHARPS CONTAINER LEFT IN THE PT'S HOME FROM THE TOP OF THE CHINA CABINET PRIOR TO ADMINISTRATION. WHEN SHE INSPECTED THE CONTAINER, SHE SAW THAT TWO NEEDLES WERE PROTRUDING FROM THE BOTTOM OF THE SHARPS CONTAINER WHICH WAS PART OF THE CHEMOTHERAPY KIT USED WHEN ADMINISTERING THE DRUG. THE NURSE WAS NOT INJURED WITH THE PROTRUDING NEEDLES, AND THE PT WAS NOT INJURED. WHEN THE DISCOVERY WAS MADE, THE NURSE IMMEDIATELY PLACED THE ROUND SHARPS CONTAINER IN THE LARGER ONE USED BY THE NURSES AT THE AGENCY, AND RETURNED BOTH CONTAINERS TO THE SUPPLY CLERK AT THE AGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMOTHERAPY 9CYTOXIC DRUGO SPILL CLEAN UP KIT-SAFETEC OF AM SPILL KIT FOR CHEMOTHERAPY SPILLS MMK SAFETEC OF AMERICA, INC. CHEMOTHERAPY SPILL CLEAN(MORE) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other