BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2192827 · Received July 20, 2011

    Report

    Report Number
    1036844-2011-00236
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 THIS EVENT TOOK PLACE IN THE INTENSIVE CARE UNIT AND THE PT HAD A HISTORY OF MENTAL ILLNESS. THE PT WAS BEING RESTRAINED DUE TO UNCOOPERATIVE BEHAVIOR. AFTER A PHYSICAL STRUGGLE WITH THE PT, IT WAS NOTED THAT THE LUMEN HAD DISLODGED FROM THE HUB. HOWEVER, THE CATHETER REMAINED IN PLACE AS SUTURES HELD IT SECURE DESPITE SIGNIFICANT TENSION ON THE DEVICE DURING THE STRUGGLE. THE CATHETER WAS REMOVED FROM THE LEFT SUBCLAVIAN AND PERIPHERAL ACCESS WAS GAINED AT A LATER STAGE FOR ADMINISTRATION OF MEDICATION. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7FR X 2 0CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK