BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 23003454 · Received September 9, 2025

    Report

    Report Number
    23003454
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 27, 2025
    Report Date
    August 28, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CHG [CHLORHEXIDINE GLUCONATE] APPLICATORS IN IV KITS (LOT NUMBER 220289) ARE YELLOW/DISCOLORED BUT NOT EXPIRED. RN [REDACTED] DISCOVERED AND REMOVED ALL IV KITS WITH THIS LOT NUMBER TO PREVENT ACCIDENTAL USE ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066130 CARDINAL HEALTH GENERAL SURGERY TRAY (KIT) LRO CARDINAL HEALTH 200, LLC MPIVBJC01L 220289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown