BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVI SOLUSET

    MDR report key: 13141 · Received May 9, 1994

    Report

    Report Number
    MW1001896
    Event Type
    Malfunction
    Date Received
    May 9, 1994
    Date of Event
    April 27, 1994
    Report Date
    April 27, 1994
    Manufacturer
    3M INFUSION THERAPY
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OBSERVATION OF THE PLASTIC PARTICULATE WAS VERIFIED. THE NEEDLE USED TO INJECT INTO THE PORT WAS INSERTED AT AN ANGLE, WHICH ALLOWED THE NEEDLE TO SCRAPE THE INSIDE OFS THE PORT AND PUSH OUT THE PLASTIC PARTICULATE THAT WAS OBSERVED IN THE BURETTE IV SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI SOLUSET BURETTE SOLUSET FPA 3M INFUSION THERAPY 1230 JUL93K01

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR