BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELEC-3

    MDR report key: 285110 · Received July 6, 2000

    Report

    Report Number
    MW1019260
    Event Type
    Malfunction
    Date Received
    July 6, 2000
    Date of Event
    July 6, 2000
    Report Date
    July 6, 2000
    Manufacturer
    BIOMEDIX INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BIOMEDIX SELEC-3 IV TUBING WAS DEFECTIVE. THE BOTTOM PORTION OF THE DRIP CHAMBER LEAKED. THIS CAUSED A DELAY IN PT CARE. THERE IS NO VISIBLE CRACK IN THE CHAMBER, IT APPEARS TO BE LEAKING AT THE GLUED POINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELEC-3 NONVENTED I.V. SET FPA BIOMEDIX INC. * 010310

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other