BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 21864495 · Received April 18, 2025

    Report

    Report Number
    21864495
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 16, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OFE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REGISTERED NURSE (RN) OPENED A CENTRAL LINE REMOVAL KIT (REF#40-3938D) AND FOUND POVIDINE/IODINE FOR THE CLEANER INSTEAD OF CHLORHEXADINE, WHICH IS THE TYPICAL CLEANER. THE CONTENTS JUST SAYS APPLICATOR PREP. WE OPENED A SECOND KIT WITH THE SAME LOT # AND IT HAD THE STANDARD SUPPLIES. MANUFACTURER RESPONSE FOR CENTRAL VENOUS BLOOD PRESSURE KIT, CARDINAL HEALTH (PER SITE REPORTER): WAITING FOR THEIR RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747684 CARDINAL HEALTH CENTRAL VENOUS BLOOD PRESSURE KIT OFE CARDINAL HEALTH 200, LLC 40-3938D 307062

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male