BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 4-LUMEN 8.5FR X 30CM

    MDR report key: 3250146 · Received July 24, 2013

    Report

    Report Number
    3006425876-2013-00140
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN KMT 11 OST, BONE MARROW TRANSPLANTATION, FLUID WAS NOTED UNDER THE SKIN NEAR THE PUNCTURE SITE. AS A RESULT, THE CATHETER WAS REMOVED AND A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344863 CVC KIT: 4-LUMEN 8.5FR X 30CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC ZF3037588

    Patients

    Seq Age Sex Outcome Treatment
    1