BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 16 CM

    MDR report key: 1203530 · Received October 17, 2008

    Report

    Report Number
    1036844-2008-00204
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE SPRING WIRE GUIDE (SWG) WAS INSERTED, THE CLINICIAN STARTED TO INSERT THE CATHETER OVER IT. HOWEVER, UPON DOING SO, THE SWG CAME OUT OF THE PROXIMAL EXTENSION LINE AND NOT THE DISTAL LIKE IT WAS MEANT TO. THE CLINICIAN ALSO REPORTED DAMAGE TO THE CATHETER AS WELL. THE CATHETER WAS EXCHANGED WITHOUT DIFFICULTY OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 7 FR X 16 CM ADUIT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC. RF8056903

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK