BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVIDER 80" TUBING, 0.2 MICRON FILTER

    MDR report key: 227150 · Received June 9, 1999

    Report

    Report Number
    MW1016510
    Event Type
    Malfunction
    Date Received
    June 9, 1999
    Date of Event
    June 8, 1999
    Report Date
    June 9, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY PT'S MOTHER: A BLACKENED AREA (APPROX 1/4") INDENTIFED INSIDE TUBING AT THE Y-PORT SITE. DESCRIBED AS LOOKING LIKE MOLD. IDENTIFIED ABOUT 1 HR AFTER START OF TPN INFUSION. TUBING CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVIDER 80" TUBING, 0.2 MICRON FILTER TUBING FPA ABBOTT LABORATORIES, INC. 13570 47038 NS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR AIM PLUS INFUSION PUMP.