BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENVER PAK

    MDR report key: 813155 · Received January 23, 2007

    Report

    Report Number
    1717671-2007-00002
    Event Type
    Malfunction
    Date Received
    January 23, 2007
    Date of Event
    December 24, 2006
    Report Date
    January 23, 2007
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Product Code
    KPM
    PMA / PMN Number
    k913728
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO THE MANUFACTURER ON 01/19/2007 FOR EVALUATION. THE ANALYSIS CODE USED BY THIS MANUFACTURER ARE NOT KNOWN.

    Description of Event or Problem · 1

    THE PHYSICIAN PUNCTURED THE RIGHT SUBCLAVIAN VEIN AND INSERTED GUIDE WIRE. THEN IT WENT TO INTERNAL JUGULAR VEIN (TOWARDS THE CEPHALIC PART). THE PHYSICIAN TRIED TO DRAW FORTH THE GUIDE WIRE SOMEWHAT, BUT IT COULD NOT MOVE WITHIN THE PUNCTURE NEEDLE AS IF IT HAD BEEN LOCKED. THE GUIDE WIRE COULD NOT BE DRAWN FORTH OR BROUGHT FORWARD EITHER. THE PHYSICIAN HAD NO CHOICE BUT TO DRAW FORTH BOTH THE GUIDE WIRE AND THE PUNCTURE NEEDLE ALL TOGETHER. THE PHYSICIAN WAS REQUIRED TO LET THE GUIDE WIRE UNFOLDED BECAUSE IT HAS CAUSED AN INCREASED AMOUNT OF THE PATIENT'S BLOOD TO FLOW. NO BLOOD TRANSFUSION WAS REQUIRED PER THE DISTRIBUTOR. THE OPERATION WAS DONE WITHOUT ANY VITAL PROBLEM, USING A GUIDE WIRE AND A PUNCTURE NEEDLE THAT WERE FROM ANOTHER MANUFACTURER. THE ALLEGED PROBLEM WAS WITH THE GUIDEWIRE AND IS NOT MANUFACTURED BY OR SPECIFICALLY MANUFACTURED FOR DENVER BIOMEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENVER PAK ASCITES SHUNT PERCUTANEOUS ACCESS KIT KPM DENVER BIOMEDICAL, INC. 42-2050 9366

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention