BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRILINE

    MDR report key: 614094 · Received June 16, 2005

    Report

    Report Number
    2245270-2005-00002
    Event Type
    Injury
    Date Received
    June 16, 2005
    Date of Event
    May 12, 2005
    Report Date
    June 8, 2005
    Manufacturer
    VYGON CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A WEEKLY ROUTINE X-RAY WAS DONE ON THE MORNING OF '05 TO EVALUATE LUNG STATUS. PHYSICIAN WAS UNABLE TO DETERMINE EXACT PLACEMENT OF PERQ. LINE. HE THEN ORDERED THE ECHO TO VERIFY PLACEMENT OF THE CATHETER AND CONTRAST X-RAY. THE PATIENT RECEIVED X-RAY WITH CONTRAST AND AN ECHOCARDIOGRAM. FOLLOWING CONFIRMATION BY ECHOCARDIOGRAM, PATIENT UNDERWENT CARDIAC CATHETERIZATION FOR REMOVAL OF BROKEN PIECE OF PERQ. LINE. THE DR. REPORTS THAT THE CATHETER SEEMS TO HAVE A PRESSURE BURST, CAUSING THE PICC TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUTRILINE PICC DQO VYGON CORP. * 022125 FE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening