BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 8FR X 2 0CM

    MDR report key: 3181649 · Received June 14, 2013

    Report

    Report Number
    3006425876-2013-00103
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 13, 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
    TW
    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 IN PULMONARY MEDICINE, THE SWG BEGAN TO UNRAVEL WHEN REMOVING IT FROM THE CATHETER PLACED IN THE PT'S INTERNAL JUGULAR VEIN. AS A RESULT, BOTH THE CATHETER AND SWG WERE REMOVED IN THEIR ENTIRETY AND W/O INTERVENTION, AND A NEW KIT WAS OPENED AND USED W/O ISSUE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO ADD'L HARM TO THE PT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271926 CVC SET: 2-LUMEN 8FR X 2 0CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC ZF2098544

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK