BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 218033 · Received April 7, 1999

    Report

    Report Number
    MW1016076
    Event Type
    Malfunction
    Date Received
    April 7, 1999
    Date of Event
    April 7, 1999
    Report Date
    April 7, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER IV STARTED, LEAKING WAS PRESENT FROM TUBING NEAR THE BOTTOM OF THE TUBING. THERE APPEARS TO BE A CUT IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER PRIMARY CONTINUOUS-FLO SET FPA BAXTER HEALTHCARE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA