BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVI

    MDR report key: 99022 · Received June 18, 1997

    Report

    Report Number
    MW1011514
    Event Type
    Malfunction
    Date Received
    June 18, 1997
    Date of Event
    May 12, 1997
    Report Date
    May 14, 1997
    Manufacturer
    3M INFUSION THERAPY
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT IN CAT SCAN-NOTED BROWN PARTICLE IN IV TUBING - MADE TECHNICIAN AWARE, THEN TURNED OFF IV AND NOTIFIED RN. PT RETURNED TO ROOM. RN DC'D IV FLUID AND TUBING. 2 BROWN PARTICLES NOTED IN TUBING. TUBING SENT TO DIRECTOR OF MATERIALS RESOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI IV TUBING FPA 3M INFUSION THERAPY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR