BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOVER

    MDR report key: 20202573 · Received September 12, 2024

    Report

    Report Number
    1423537-2024-00153
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 18, 2024
    Report Date
    November 20, 2024
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    FCM
    UDI-DI
    10884521016668
    PMA / PMN Number
    K903340
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 2319843 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE REPORTED CONDITION WAS OBSERVED; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 THE CATHETER BALLOON WAS BURST INSIDE THE PATIENT AND A CHUNK OF THE SILICONE REMAINED IN THE PATIENT¿S BLADDER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE FOLEY WAS INSERTED ON (B)(6) 2024, AT 18:28 AND THE TEAM NOTICED FOLEY HAD COME OUT AT 19:15. THE BALLOON WAS NOT INTACT. PER CUSTOMER, CYSTOSCOPY PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENTS IN THE PATIENT¿S BLADDER. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592059 DOVER TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT) FCM CARDINAL HEALTH, INC. 8887605148 2319843 10884521016668

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other