BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 18623610 · Received February 1, 2024

    Report

    Report Number
    9610711-2024-00026
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    October 24, 2023
    Report Date
    June 4, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040144572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 9132281 WITH THE SAME DEFECT. THIS PRODUCT WAS MADE BY OUR SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS ISSUE. IN FEBRUARY WE RECEIVED DOCUMENTATION OF INVESTIGATION FROM OUR SUBCONTRACTOR, THE PROBABLE ROOT CAUSE OF THIS ISSUE WAS THE RAW MATERIAL OF THE BALLOON. WE RECEIVED THE INCRIMINATED SAMPLE. AFTER DECONTAMINATION, WE NOTED THAT THE BALLOON WAS BURST WITHOUT MISSING PART. CHECKING THE QUALITY DATABASES REVEALED ONE NON-CONFORMITY IN RELATION TO THE DESCRIBED DEFECT AND A CORRECTIVE AND PREVENTIVE ACTION: - NC (B)(4): "PB BALLONS (BULLES + AGGLUTINÉS)" OPENED IN 16 JANUARY 2023. FOR THIS NC, THE USED OF CLUMPED BALLOONS SHOULD BE RESPONSIBLE OF SOME WEAKNESS ON THE BALLOON AND BEING RESPONSIBLE OF BURSTING. - MONITORING CAPA-000152: "BALLOON ISSUES ON FOLYSIL AND SILICONE PROSTATIC CATHETERS". THE TRENDING FOR BALLOON BURSTING IS SPECIFICALLY MONITORED. A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME ITEM NUMBER AB63 SAME DEFECT: BALLOON BURST OVER LAST FOUR YEAR: 53 SIMILAR CASE WERE FOUND.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST/RUPTURED. NO SERIOUS CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST/RUPTURED. NO SERIOUS CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109832 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9132281_AB63241002 03600040144572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention