BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 19126305 · Received April 17, 2024

    Report

    Report Number
    9610711-2024-00084
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    March 15, 2024
    Report Date
    June 28, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040144312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9445830. ON 17TH MAY WE RECEIVED DOCUMENTARY INVESTIGATION FROM OUR SUBCONTRACTOR: THE PROBABLE ROOT CAUSE OF THIS ISSUE WAS A PROBLEM WITH BALLOON¿S RAW MATERIAL. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS KNOWN AND CLOSELY MONITORED. A SIMILAR CASE STUDY WAS ALSO PERFORMED BASED ON SAME ITEM NUMBER AND SAME DEFECT [BALLOON BURST] FROM MARCH 2020 TO MARCH 2024, 45 SIMILAR CASES WERE FOUND. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED AND CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION WHEN REMOVING THE CATHETER, THE NURSE DISCOVERED A DEFECTIVE BALLOON. THE BALLOON HAD A HOLE IN ABOUT 3 CM IN SIZE. A NEW CATHETER WAS NOT INSERTED AND NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934800 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 789789789 9445830_AB63201002 03600040144312

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown