BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 8FR X 2 OCM

    MDR report key: 2993029 · Received March 1, 2013

    Report

    Report Number
    3006425876-2013-00024
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INVOLVED WAS A (B)(6) FEMALE WEIGHING (B)(6) TALL. IN THE HEMATOLOGY DEPARTMENT, DURING THE INSERTION OF THE DILATOR OVER THE SWG INTO THE PATIENT'S RIGHT SUBCLAVIAN VEIN, RESISTANCE WAS MET MAKING INSERTION DIFFICULT. AS A RESULT, THE USER FORCED THE DILATOR THROUGH THE FASCIA, WHICH IN TURN CAUSED THE DILATOR TO "RUPTURE" ALSO CAUSING DAMAGE TO THE WALL OF THE VEIN AND TISSUE. THE DILATOR WAS NOT REMOVED UNTIL DILATION WAS COMPLETE, INSTEAD IT WAS FORCED USING ROTARY MOTION UNTIL DILATOR WAS IN PLACE. IT WAS AT THE TIME OF REMOVAL THAT THE DILATOR WAS FOUND DAMAGED. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89518 CVC SET: 2-LUMEN 8FR X 2 OCM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC ZF2076120

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR