BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP

    MDR report key: 1600087 · Received January 29, 2010

    Report

    Report Number
    1600087
    Event Type
    Malfunction
    Date Received
    January 29, 2010
    Date of Event
    January 29, 2010
    Report Date
    January 29, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE NURSING STAFF REPORTED A PROBLEM WITH THE CHLORAPREP APPLICATOR THAT IS CONTAINED IN THE IV START KIT. THE VIAL OF CHLORAPREP IS DIFFICULT TO BREAK. WHEN THE VIAL BREAKS, THE GLASS IS EITHER CUTTING THE END OF THE APPLICATOR TUBE OR THE FORCE REQUIRED TO BREAK THE VIAL IS CAUSING THE TUBE TO CRACK. CHLORAPREP IS LEAKING FROM THE APPLICATOR TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHLORAPREP SEPP APPLICATOR KXF CARDINAL HEALTH * 33055

    Patients

    Seq Age Sex Outcome Treatment
    1 *