BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 1760746 · Received July 13, 2010

    Report

    Report Number
    MW5016729
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    KGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING INSERTION OF A CENTRAL LINE CATHETER USING AN ARROW TRIPLE LUMEN PRE-PACKAGED CENTRAL LINE INSERTION TRAY, WHEN THE PHYSICIAN REMOVED THE GUIDEWIRE, THE GUIDEWIRE WAS NOTED TO BE COMING UNRAVELED. NO KNOWN OR APPARENT INJURY TO THE PT WAS SUSTAINED. LOT # RF 0035076.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW TRIPLE LUMEN CENTRAL LINE INSERTION TRAY KGZ ARROW INTERNATIONAL INC RF 0035076

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR