BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMP

    MDR report key: 510854 · Received January 30, 2004

    Report

    Report Number
    MW1031059
    Event Type
    Malfunction
    Date Received
    January 30, 2004
    Date of Event
    December 16, 2003
    Report Date
    January 30, 2004
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAULTY WIRE FROM PICC LINE KIT, MAGNUM 2 CATH, WIRE WOULD NOT PULL OUT OF CATHETER. HAD TO PULL CATHETER WIRE & SHEATH. SHEATH REPLACED & NEW WIRE USED TO REPLACE CATHETER. PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HMP MAGNUM Z CATH DQO HORIZON MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other