BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 20 CM

    MDR report key: 1030959 · Received April 16, 2008

    Report

    Report Number
    1036844-2008-00061
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THE HOSPITAL IS RETAINING THE CATHETER AND SWG AND WILL NOT RELEASE. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE RISK MANAGER, THAT THE CATHETER WAS BEING USED ON A FEMALE PATIENT DURING A CODE. MD INSERTED CATHETER WITHOUT DIFFICULTY INTO THE RIGHT SUBCLAVIAN VEIN. HE THEN REMOVED THE SPRING WIRE GUIDE (SWG) & NOTICED THAT PART OF THE SWG WAS GONE. A CHEST X-RAY WAS PERFORMED & NO SWG WAS VISIBLE. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT WHERE THE EMERGENCY DEPARTMENT NURSE & RISK MANAGER OPENED ANOTHER KIT & COMPARED THE SWG THAT WAS USED WITH A NEW ONE. IT WAS NOTED THAT APPROXIMATELY 3.5 TO 4 INCHES WAS INDEED MISSING. LOCATION OF THE MISSING WIRE WAS A CONTINUAL PROCESS & ONE OF THE SURGEONS ON STAFF EXCHANGED THE CATHETER IN USE FOR ANOTHER ONE. HE TOOK THE OLD CATHETER TIP & CUT IT IN SEVERAL PIECES FINDING THE DISLOCATED SWG IN THE END OF THE CATHETER TIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 7 FR X 20 CM ARROW G+ARD CATHETER PRODUCTS DQO ARROW INTL., INC. RF5107745

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR