BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 19132962 · Received April 18, 2024

    Report

    Report Number
    19132962
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    January 19, 2024
    Report Date
    January 29, 2024
    Manufacturer
    CAREFUSION 213, LLC
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE WAS GOING TO USE CHLOAREP APPLICATOR TO CLEAN SURFACE. WHEN THE WINGS WERE PRESSED TO CRACK THE CASING AND ENGAGE THE FLUID, THERE WAS NO FLUID AVAILABLE. THE CRACKED PIECES WERE LOSE IN THE CHAMBER AND EXTENDED DOWN TO THE CLEANING CUSHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284510 CHLORAPREP ONE STEP APPLICATOR, ABSORBENT TIPPED, STERILE KXG CAREFUSION 213, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown