BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD PRIMARY IV SET

    MDR report key: 221592 · Received April 30, 1999

    Report

    Report Number
    MW1016236
    Event Type
    Malfunction
    Date Received
    April 30, 1999
    Date of Event
    April 26, 1999
    Report Date
    April 30, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV SET WAS PRIMED AND CONNECTED TO PT. AFTER A SHORT PERIOD, CAREGIVER NOTICED DRIPPING ON FLOOR, LEAKING TUBING WHICH WAS DISCONTINUED. CAREGIVER FELT NO EFFECT TO PT RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD PRIMARY IV SET IV TUBING FPA ABBOTT LABORATORIES, INC. 11309 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *