BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 515925 · Received March 3, 2004

    Report

    Report Number
    MW1031412
    Event Type
    Malfunction
    Date Received
    March 3, 2004
    Date of Event
    February 18, 2004
    Report Date
    February 26, 2004
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REGULAR IV TUBING WAS CONNECTED TO EPIDURAL AND PUMP IN THE O.R. FLOOR NURSE TRACED TUBING BEFORE ADMINISTERING DOSE OF IV ZOFRAN. TUBING CHANGED TO APPROPRIATE EPIDURAL TUBING WITH YELLOW STRIP AND PROPERLY TAGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT IV TUBING FPK ABBOTT LABORATORIES 09011943 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR PLUM XL EPIDURAL PUMP,| EPIDURAL TUBING - #11041100.