BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 20787505 · Received November 26, 2024

    Report

    Report Number
    9610711-2024-00331
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 28, 2024
    Report Date
    April 11, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K233411
    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 ANY OTHER COMPLAINTS ON THE LOT NUMBER 9845321. B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND ANY OTHER COMPLAINT ON THE LOT NUMBER 9845321. IN FEBRUARY, WE RECEIVED FOUR SEALED SAMPLES. THESE MEDICAL DEVICE WERE TESTED. BALLOONS WERE INFLATED AT 10 ML OF WATER DURING 8 DAYS. NO DEFLATION OR BURSTING ISSUE WAS OBSERVED DURING THIS PERIOD. BALLOON BURSTING ISSUE IS KNOWN BUT ACCORDING TO THE AVAILABLE INFORMATION, WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE IN THIS CASE. QUALITY DATABASE WAS CHECKED AND REVEALED A CORRECTIVE AND PREVENTIVE ACTION CAPA-000152. "BALLOON ISSUES ON FOLYSIL AND SILICONE PROSTATIC CATHETERS" WAS OPENED AND MONTHLY MONITORING. 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 FOLYSIL PRODUCT, DEFECT BURST FROM OCTOBER 2020 TO OCTOBER 2024, 210 SIMILAR CASES WERE FOUND. A RMF EVALUATION WAS PERFORMED BASED ON CRIQ247 - RISK IDENTIFIED 11304 (HAZARDOUS SITUATION: CATHETER BALLOON CANNOT BE INFLATED (OR WITH DIFFICULTY) THE EVALUATION HAS SHOWED THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART LEVEL. 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 BALLOON OF THE CATHETER BURST WHEN FILLED. THE NURSE USED AMPOULE OF STERILE WATER IN THE URINARY CATHETER SET TO FILL IT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON OF THE CATHETER BURST WHEN FILLED. THE NURSE USED AMPOULE OF STERILE WATER IN THE URINARY CATHETER SET TO FILL IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878539 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9845321_AA61184002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown