BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-TECH

    MDR report key: 424522 · Received October 23, 2002

    Report

    Report Number
    MW1026537
    Event Type
    Injury
    Date Received
    October 23, 2002
    Date of Event
    September 20, 2002
    Report Date
    October 8, 2002
    Manufacturer
    MEDI TECH
    Product Code
    FOZ
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "SITE APPEARS SWOLLEN WHEN RED PORT FLUSHED, FLUID LEAKS FROM INSERTION SITE OF Y CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TECH VAXCEL CATHETER FOZ MEDI TECH 5 FR PICC 2 LUMENS 617062C

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention