BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING

    MDR report key: 18222007 · Received November 28, 2023

    Report

    Report Number
    9610711-2023-00255
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Report Date
    June 13, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040260753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION, THE LOT NUMBER IS AVAILABLE BUT NOT THE SAMPLE. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND FOUND NONE ON THE LOT NUMBER 9240226. CHECKING THE QUALITY DATABASES REVEALED ONE NON-CONFORMITY (NC) POTENTIALLY IN RELATION TO THE DESCRIBED DEFECT AND A CORRECTIVE AND PREVENTIVE ACTION (CAPA): - 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 ITEM NUMBER XB63, DEFECT BALLOON DEFLATION. BALLOON BURST; DEFECTIVE BALLOON OVER LAST FOUR YEAR, 42 SIMILAR CASES WERE FOUND.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION UPON INSERTION OF THE CATHETER, THE BALLOON BURST ON INFLATION AT 30ML. NO CLINICAL CONSEQUENCE FOR THE PATIENT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION UPON INSERTION OF THE CATHETER, THE BALLOON BURST ON INFLATION AT 30ML. NO CLINICAL CONSEQUENCE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532167 HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9240226_XB63181002 03600040260753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown