BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 7FR X 2 0CM

    MDR report key: 2192823 · Received July 20, 2011

    Report

    Report Number
    1036844-2011-00237
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE EMERGENCY ROOM, THE MD WAS ATTEMPTING TO REMOVE THE SPRING WIRE GUIDE (SWG) FROM THE CATHETER THAT WAS PLACED IN THE PT'S JUGULAR VEIN. WHILE PULLING ON IT TO REMOVE, THE SWG UNRAVELED AND AS A RESULT BOTH THE CATHETER AND SWG WERE REMOVED TOGETHER AND IN ITS ENTIRETY. A NEW SET WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 7FR X 2 0CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF0116636

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK