BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 1000373 · Received February 19, 2008

    Report

    Report Number
    MW5005590
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 10, 2008
    Report Date
    February 11, 2008
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008 GROSHONG DUAL LUMEN CATHETER IMPLANTED IN UPPER RIGHT CHEST AREA. TWO DAYS LATER, DURING FLUSHING, MEDICAL ASSISTANT NOTICED A LEAK IN ONE OF THE TWO SMALL LINES ENTERING THE BODY. REPEATED EFFORTS TO FLUSH THE BROKEN LINE WERE UNSUCCESSFUL. AND, BECAUSE THE LINE LEAK WAS AT THE ENTRANCE OF THE BODY, IT COULD NOT BE REPAIRED. PIN HOLE. A NEW DUAL LUMEN CATHETER WAS IMPLANTED ABOUT 9 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS GROSHONG DQO

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| O