BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 16806556 · Received April 25, 2023

    Report

    Report Number
    16806556
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    April 11, 2023
    Report Date
    April 17, 2023
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    NWU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FIVE CARDINAL HEALTH 200, LLC. UROLOGICAL SURGICAL PROCEDURE KITS WERE UNSEALED AND NOT STERILE. ALL WERE FROM THE SAME LOT NUMBER 992973 WITH A MANUFACTURER DATE OF 02-02-2023. ITEMS WERE NOT USED AND SET ASIDE. MANUFACTURER RESPONSE FOR ENDOSCOPE INTRODUCER KIT, CARDINAL HEALTH (PER SITE REPORTER). NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336251 CARDINAL HEALTH ENDOSCOPE INTRODUCER KIT NWU CARDINAL HEALTH 200, LLC SBA56PUIMB 992973

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown