BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 18118763 · Received November 13, 2023

    Report

    Report Number
    9610711-2023-00243
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Report Date
    June 13, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040278369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN NOVEMBER, WE RECEIVED ONE USED SAMPLE. WE OBSERVED THAT BALLOON WAS BURST WITHOUT MISSING PART. THE SAMPLE HAD A RED VALVE CH18 LOT NUMBER 8854622. AFTER MADE A TRACKING WE FOUND THAT THE PRODUCT REFERENCE IS (B)(4) LOT NUMBER 9041111 MANUFACTURED IN FEBRUARY 2023 FOR (B)(4). THE EXPIRY DATE IS FEBRUARY 2028. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT REGARDING THE LOT NUMBER 9041111. CHECKING THE QUALITY DATABASES REVEALED ONE NON-CONFORMITY IN RELATION TO THE DESCRIBED DEFECT AND A CORRECTIVE AND PREVENTIVE ACTION ARE ONGOING: NC (B)(4): "PB BALLONS (BULLES + AGGLUTINÉS)" OPENED IN 16 JANUARY 2023. CAPA-000152: "BALLOON BURSTING TRENDING FOR FOLYSIL AND SILICONE PROSTATIC CATHETERS". THE TRENDING FOR BALLOON BURSTING IS SPECIFICALLY MONITORED. A SIMILAR CASE STUDY WAS PERFORMED BASED ON ITEM NUMBER AB6R, DEFECT BALLOON DEFLATION. BALLOON BURST; DEFECTIVE BALLOON OVER LAST FOUR YEAR, 15 SIMILAR CASES WERE FOUND. TO OUR KNOWLEDGE / UNDERSTANDING OF THE EVENT, THE PROSTATIC CATHETER REF. AB6R18 WAS PLACED FOR UNKNOWN INDICATION AND THE BALLOON BURST (¿FISSURE¿) WHEN THE PATIENT RETURNED TO HIS ROOM REQUIRING RE-INTERVENTION FOR CHANGE OF CATHETER POSSIBLY UNDER GENERAL ANESTHESIA, WHICH IS SEVERITY PARAMETER 3.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THAT WHEN THE PATIENT WAS TURNED OVER IN BED, THE URINARY CATHETER FELL OUT AND THE BALLOON WAS OBSERVED TO BE DEFLATED. WHEN THE HEALTHCARE PROFESSIONAL TESTED THE BALLOON, A FISSURE WAS NOTED IN THE BALLOON. A NEW CATHETER WAS INSERTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THAT WHEN THE PATIENT WAS TURNED OVER IN BED, THE URINARY CATHETER FELL OUT AND THE BALLOON WAS OBSERVED TO BE DEFLATED. WHEN THE HEALTHCARE PROFESSIONAL TESTED THE BALLOON, A FISSURE WAS NOTED IN THE BALLOON. A NEW CATHETER WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219963 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 03600040278369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown