BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 19154594 · Received April 22, 2024

    Report

    Report Number
    9610711-2024-00091
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    March 19, 2024
    Report Date
    July 1, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040144183
    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 COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINTS REGARDING THE LOT NUMBER 8931551. THIS PRODUCT WAS MADE BY OUR SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS ISSUE. WE RECEIVED A DOCUMENTARY INVESTIGATION FROM OUR SUBCONTRACTOR: THE PROBABLE ROOT CAUSE OF THIS ISSUE WAS A PROBLEM WITH BALLOON¿S RAW MATERIAL. WE RECEIVED ONE USED SAMPLE. WE OBSERVED THAT BALLOON WAS BURST WITHOUT MISSING PART. MOREVER, THE CATHETER AT THE FUNNEL LEVEL IS BROKEN. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS KNOWN AND CLOSELY MONITORED A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME ITEM NUMBER AB63XX, DEFECT: BURST, OVER THE LAST FOUR YEARS: 33 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 THE BALLOON HAD TORN. PATIENT WAS RE-CATHETERIZED WITH SLIGHT HEMATURIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111334 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 8931551_AB63181002 03600040144183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown