BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2933133 · Received January 22, 2013

    Report

    Report Number
    2933133
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    PICC LINE PLACED. APPROXIMATELY NINETEEN (19) DAYS LATER, THE IV BEEPED INDICATING A DISTAL LINE OCCLUSION. A SMALL AMOUNT OF BLOOD WAS NOTED, AND THE NURSE ATTEMPTED TO FLUSH THE LINE BUT WAS UNABLE TO DO SO. A HEPARINIZED FLUSH WAS THEN OBTAINED, AND THE LINE WAS FLUSHED BUT STILL WITH SOME DIFFICULTY. A FINE MIST THEN ERUPTED FROM THE HUB OF THE PICC AND THEN DROPS OF FLUID BEGAN TO LEAK; AN ATTEMPT WAS MADE TO SEAL THE LEAK WITH TEGADERM, AND THE LINE WAS UNABLE TO BE FLUSHED AT ALL. THE PICC HAD TO BE PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31549 FIRST PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 D FOZ ARGON MEDICAL DEVICES, INC. * 11022591

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DAY NO OTHER THERAPIES