BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7FR X 2 0 CM

    MDR report key: 3190672 · Received June 24, 2013

    Report

    Report Number
    9680794-2013-00030
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE ICU DURING INSERTION INTO THE PATIENT'S LEFT SUBCLAVIAN, THE SWG "LOST ITS INTEGRITY" (UNRAVELED). AS RESULT, BOTH THE CATHETER AND SWG WERE REMOVED AND REPLACED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO HARM TO THE PATIENT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE. THE PATIENT INVOLVED WAS (B)(6) MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285467 CVC SET: 3-LUMEN 7FR X 2 0 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. CF2125705

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR