BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 12 FR X 20 CM

    MDR report key: 3960084 · Received May 29, 2014

    Report

    Report Number
    1036844-2014-00226
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K970864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS COMPLAINT INVOLVED A (B)(6) PATIENT. AT THE TIME OF THE PROCEDURE THE PATIENT WEIGHTED 92.2 KG, AND STOOD 160 CM TALL. IT WAS REPORTED THAT IN THE ICU DURING INSERTION INTO THE PATIENT'S SUBCLAVIA, THE SWG "UNCOILED AND GOT FIXED INTO THE CATHETER". AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO DELAY, HARM, COMPLICATION, DEATH, OR INJURY REPORTED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315885 CVC SET: 3-LUMEN 12 FR X 20 CM ADULT MULIT-LUMEN CATHETER PRODUCTS FOZ ARROW INTL., INC. 23F13J0421

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR