BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG CATHETER

    MDR report key: 1203573 · Received October 16, 2008

    Report

    Report Number
    3006260740-2008-00153
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    June 27, 2008
    Report Date
    September 24, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IT WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GROSHONG CATHETER WAS IMPLANTED 18 MONTHS AGO TO INFUSE FLOLAN. A LEAKAGE WAS NOTICED DURING CONTRAST MEDIA INFUSION. A SPLIT OF THE EXTERNAL PART OF THE HUB WAS ALSO MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG CATHETER IMPLANTED LONG TERM INTRAVASCULAR CATHETER DQO C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention