BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-TYPE EXTENSION SET WITH OPTION LOK

    MDR report key: 2223365 · Received August 15, 2011

    Report

    Report Number
    2223365
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    May 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    WHILE CAREFULLY CHECKING IV TUBING AND PHASEAL SYSTEM, THIS NURSE NOTED A SMALL AMOUNT OF ORANGE LIQUID AROUND THE JOINT OF THE FEMALE PIECE OF PHASEAL SYSTEM JOINED TO Y CONNECTOR. THE MANNITOL HAD BEEN RUNNING THROUGH THIS HALF OF THE Y CONNECTOR, THOUGH IT APPEARED AS THOUGH DOXORUBICIN AT SOME POINT IN TIME HAD BACKED UP INTO THIS PART OF THE Y CONNECTOR AND HAD LEAKED AROUND THE JOINT. THE NURSE CHECKED TO SEE THAT THE FEMALE PIECE OF THE PHASEAL WAS TIGHT. THE CONNECTIONS WERE NOTED TO BE TIGHT. FIVE SMALL PEA-SIZED STAINS NOTED TO PATIENT'S PANTS, SHIRT AND CHUX PAD. Y-CONNECTOR WAS CHANGED OUT AND ADDED TO CURRENT PHASEAL SYSTEM AFTER PREVIOUS Y WAS FLUSHED. THE PHASEAL SYSTEM WAS ALSO CHECKED, BUT FOUND TO BE INTACT. PATIENT CHANGED CLOTHING AND THERE WAS NO CONTACT OF THE SKIN WITH THE HAZARDOUS MEDICATION. THE NURSE FELT THAT THE PROBLEM WAS WITH THE Y TYPE CONNECTOR AND NOT THE PHASEAL SYSTEM. BECAUSE OF THE NATURE OF THE DRUG, THE PIECES WERE NOT SAVED. THIS IS A HAZARDOUS MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-TYPE EXTENSION SET WITH OPTION LOK INTRAVASCULAR TUBING FPA HOSPIRA * 82084NS

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES