BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHURCHILL MEDICAL SYSTEMS

    MDR report key: 1033405 · Received April 22, 2008

    Report

    Report Number
    MW5006381
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 22, 2008
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERILE EXTENSION SET -14 INCH- FROM CHURCHILL MEDICAL SYSTEMS INC. PRODUCT LOT # 803011. WHEN THE RN OPENED, THE PACKAGE SHE FOUND THE EXTENSION SET WAS CUT IN HALF, THE PACKAGE WAS STILL INTACT. THE RN WAS ABLE TO DO THE INFUSION WITHOUT THE EXTENSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHURCHILL MEDICAL SYSTEMS 14 IN STERILE EXTENSION SET FPA CHURCHILL MEDICAL SYSTEMS INC. 803011

    Patients

    Seq Age Sex Outcome Treatment
    1