BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT GRAVITY FLOW

    MDR report key: 284535 · Received June 29, 2000

    Report

    Report Number
    MW1019220
    Event Type
    Malfunction
    Date Received
    June 29, 2000
    Date of Event
    June 9, 2000
    Report Date
    June 29, 2000
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE IV TUBING ATTACHED. STOPCOCK TO NEEDLELESS PORT. PORT DID NOT ALLOW STOPCOCK TO FUNCTION PROPERLY. WHEN STOPCOCK CHANGED PORT APPEARED STICKY AND PARTIALLY BROKEN. USED PRN CAP ON PORT WHICH FUNCTIONED PROPERLY. NOTE: REQUIRED RN TO USE A NEEDLE WHEN SAFETY DEVICE SHOULD HAVE WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT GRAVITY FLOW PRIMARY IV TUBING FPA ABBOTT LABORATORIES, INC. NOT AVAILABLE *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other