BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHURCHILL MEDICAL SYSTEM

    MDR report key: 1352756 · Received March 24, 2009

    Report

    Report Number
    1352756
    Event Type
    Malfunction
    Date Received
    March 24, 2009
    Date of Event
    March 16, 2009
    Report Date
    March 24, 2009
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    LRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN IV START FOR SURGERY THE CHLORAPREP FREPP SPONGE WAS ACTIVATED AND GLASS FRAGMENTS WERE IN THE SPONGE LEADING TO A SUPERFICIAL CUT ON THE PATIENT'S ARM.======================MANUFACTURER RESPONSE FOR IV START KIT, CHURCHILL MEDICAL SYSTEM======================WILL EVAULATE THE PRODUCT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHURCHILL MEDICAL SYSTEM KIT, IV SITE PREP LRS CHURCHILL MEDICAL SYSTEMS, INC. AMS-796CP 810124

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR