BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-CORING NEEDLE WINGED INFUSION SET

    MDR report key: 35183 · Received August 12, 1996

    Report

    Report Number
    MW1009694
    Event Type
    Injury
    Date Received
    August 12, 1996
    Date of Event
    July 13, 1996
    Report Date
    August 1, 1996
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    7/13/96 AT 1500 THE PT WAS RECEIVING TPN VIA AN IMPLANTABLE PORT WHICH WAS ACCESSED WITH AN NON-CORING WINGED INFUSION SET. THE TUBING FROM THE SET PULLED AWAY FROM THE NEEDLE WHICH WAS IN THE PORT, A VENOUS ACCESS SYSTEM. THE NEEDLE STAYED IN THE PORT RESULTING IN THE PT BLEEDING APPROX 5-10 CC BLOOD FROM THE PORT BEFORE THE PT'S MOTHER COULD PULL THE NEEDLE OUT OF THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-CORING NEEDLE WINGED INFUSION SET Implant IV ADMINISTRATION SET FMI CHURCHILL MEDICAL SYSTEMS, INC. 6A126

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Required Intervention