BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED COMP

    MDR report key: 430360 · Received November 25, 2002

    Report

    Report Number
    430360
    Event Type
    Malfunction
    Date Received
    November 25, 2002
    Date of Event
    September 27, 2002
    Report Date
    November 20, 2002
    Manufacturer
    MED COMP
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRACK IN PERM CATH VENOUS "POA" (AIR BUBBLES NOTED). MED COMP NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED COMP ASH POA CATH MSD MED COMP * M480820

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other