BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 21379257 · Received February 13, 2025

    Report

    Report Number
    21379257
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 5, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    NWU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CYSTO KIT PBDS (PROCEDURE-BASED DELIVERY SYSTEMS) WITH 9 RAYTEC INSTEAD OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126854 CARDINAL HEALTH ENDOSCOPE INTRODUCER KIT NWU CARDINAL HEALTH 200, LLC SOT12CYHMA 380832

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male