BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 20397350 · Received October 8, 2024

    Report

    Report Number
    9610711-2024-00276
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 1, 2024
    Report Date
    December 20, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT REGARDING THE LOT NUMBER 9792190. B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED DATE. ON 24TH SEPTEMBER, WE RECEIVED ONE USED SAMPLE. AFTER DECONTAMINATION, WE OBSERVED THAT THE BALLOON WAS BURST WITHOUT MISSING PART. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND ANY OTHER COMPLAINTS REGARDING THE LOT NUMBER. THIS PRODUCT WAS MADE BY OUR SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS ISSUE. A BALLOON BURST COULD COME FROM VARIOUS CAUSES BUT ACCORDING TO THE AVAILABLE INFORMATION, WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE IN THIS CASE. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS KNOWN AND CLOSELY MONITORED. NO CORRECTIVE ACTION WILL BE IMPLEMENTED AS OUR TREND IS NOT INCREASING AND THE THRESHOLD IS NOT EXCEEDED. A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME PRODUCT AND SAME DEFECT "BURST", OVER THE LAST FOUR YEARS, 123 SIMILAR CASES WERE FOUND. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED AND THE EVALUATION HAS SHOWN THAT THE RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART. BASED ON THIS, WE CAN CONCLUDE THAT RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER WAS INSERTED AT 4PM, THE BALLOON INFLATED WITH PPI WATER (40ML). AT AROUND 7:30PM, THE PATIENT NOTICED THAT THE CATHETER WAS NO LONGER EVACUATING ANYTHING. HE INFORMED THE NURSING STAFF, WHO REMOVED THE CATHETER AND DISCOVERED THAT THE BALLOON HAD BEEN PUNCTURED AND THAT THE CATHETER HAD MOVED. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20680 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9792190_AB63181002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown