BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1873370 · Received September 17, 2010

    Report

    Report Number
    1036844-2010-00291
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSERTION, THE TIP OF THE SPRING WIRE GUIDE (SWG) WAS FOUND BROKEN AND UNABLE TO USE WHEN ADVANCING THROUGH THE CATHETER. THE INSERTION SITE WAS THE JUGULAR VEIN. A NEW KIT WAS OPENED AND USED WITHOUT DIFFICULTY OR COMPLICATIONS TO THE PT. ADDITIONAL INFO RECEIVED ON 09/10/2010 FROM THE DISTRIBUTOR STATED: "THE CATHETER REFERS TO THE CVC CATHETER AND YES THE SWG WAS INSERTED INTO THE PT. NOTHING ABNORMAL WAS FOUND BEFORE SETUP; HOWEVER, DURING THE INSERTION PROCEDURE WHEN CUSTOMER WAS ADVANCING THE CVC INTO THE PT OVER THE SWG, RESISTANCE WAS FELT AND THE SWG WAS THEN REMOVED FROM THE PT AND THE FRACTURE AT THE TIP WAS FOUND."

    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. RF9112641

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK