BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELEC-3

    MDR report key: 377491 · Received February 13, 2002

    Report

    Report Number
    MW1024090
    Event Type
    Malfunction
    Date Received
    February 13, 2002
    Date of Event
    February 12, 2002
    Report Date
    February 13, 2002
    Manufacturer
    BIOMEDIX, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EMERGENCY MEDICAL TECHNICIAN "SPIKED" IV BAG WITH REPORTED DEVICE, SQUEEZED ON DRIP CHAMBER TO PRIME CHAMBER WITH FLUID, AT WHICH TIME DRIP CHAMBER RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELEC-3 IV TUBING FPA BIOMEDIX, INC. B41-102 201741

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other