BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 12 FR X 20 CM

    MDR report key: 2192792 · Received July 20, 2011

    Report

    Report Number
    1036844-2011-00239
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPRING WIRE GUIDE (SWG) WAS FOUND UNRAVELED WHEN REMOVING FROM THE SYRINGE. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT. ADD'L INFO RECEIVED ON (B)(6) 2011 FROM THE DISTRIBUTOR STATED THAT THE SWG WAS REMOVED IN ITS ENTIRETY, THE INSERTION SITE WAS THE INTERNAL JUGULAR VEIN AND RESISTANCE WAS FELT WHEN ADVANCING THROUGH THE ARROW RAULERSON SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 12 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF1019978

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK