BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOVER

    MDR report key: 20516171 · Received October 23, 2024

    Report

    Report Number
    1423537-2024-00259
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Report Date
    January 24, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    KOD
    PMA / PMN Number
    K833790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 2211531 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. A DEVICE WAS RECEIVED FOR EVALUATION AND THE REPORTED CONDITION WAS OBSERVED; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE FOREIGN MATERIAL INSIDE THE RETURNED DEVICE DOESN¿T BELONG TO A MATERIAL USED IN ANY OF OUR MANUFACTURING PROCESS. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS A PIECE INSIDE THEREFORE BLOCKING URINE WHICH IN TURN CAUSED PAIN AND OR DISCOMFORT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS A BLACK PIECE FOUND ON THE URINE DRAINAGE PORT OF THE CATHETER. THE CUSTOMER FURTHER STATED THAT THERE WAS NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30324 DOVER CATHETER, UROLOGICAL KOD CARDINAL HEALTH, INC. 20514C 2211531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown