BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEGUARD NON-CORING SAFETY INFUSION SET

    MDR report key: 3519092 · Received December 9, 2013

    Report

    Report Number
    MW5033327
    Event Type
    Injury
    Date Received
    December 9, 2013
    Date of Event
    November 15, 2013
    Report Date
    December 6, 2013
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE AN ALLERGIC REACTION TO A CHEST PORT NEEDLE. I SUSPECT IT IS THE 8-11% NICKEL THAT THE MFR SAYS IS IN THE STAINLESS STEEL. THE SITE ITCHES, MY THROAT ITCHES, AND BREATHING IS DIFFICULT AS LONG AS THE PORT IS ACCESSED WITH THIS NEEDLE. THE REACTION SUBSIDES AFTER I AM DEACCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637552 LIFEGUARD NON-CORING SAFETY INFUSION SET LIFEGUARD NON-CORING SAFETY INFUSION SET FMI CHURCHILL MEDICAL SYSTEMS, INC. CLG 2234

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other