BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDC CORPORATION

    MDR report key: 124882 · Received October 7, 1997

    Report

    Report Number
    124882
    Event Type
    Malfunction
    Date Received
    October 7, 1997
    Date of Event
    October 6, 1997
    Report Date
    October 6, 1997
    Manufacturer
    HDC CORP
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PICC LINE WAS BEING PLACED IN PATIENT. THIS WAS A CLEAN STICK WITH GOOD BLOOD BACK-FLOW. CATHETER WAS ADVANCED ABOUT 10CM BEFORE IT STOPPED. UNABLE TO ADVANCE FURTHER. FLUSHED WITH SOME RESISTANCE. IT WAS REMOVED TO ATTEMPT AT A DIFFERENT SITE. UPON REMOVING, IT WAS NOTED THAT THE END HED FRAYED OFF FROM THE STYLET - ONLY A SMALL PIECE OF CATHETER WAS SHOWING FROM NEEDLE SITE. 10 CM PULLED FROM PATIENT'S ARM. BEVELED END WAS INTACT, ABOUT 60 CM PRE & POST WITH FRAYED TIP INCLUDED. SIMPLE FLUIDS WERE FLUSHED. THERE WAS NO LONG TERM ADVERSE EFFECT TO THE PATIENT (THE PROCESS WAS PAINFUL) AND HE DID NOT REQUIRE SURGERY TO REMOVE THE CATHETER END. THIS IS THE FIRST TIME THE HOSPITAL HAS USED THIS PRODUCT SINCE THE STYLE WAS CHANGED (WING REINFORCEMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HDC CORPORATION V-CATH PICC SINGLE LUMEN CATHETER DQO HDC CORP 360-40 *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR