BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 18809123 · Received February 29, 2024

    Report

    Report Number
    9610711-2024-00048
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    January 29, 2024
    Report Date
    July 2, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040126844
    PMA / PMN Number
    K013174
    Adverse Event
    Yes
    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 FOUND ANOTHER COMPLAINT ON THE LOT N° 9445801 (B)(4). THE AA61061002 LOT 9445801 HAS BEEN PACKAGED WITH INTERMEDIATE PRODUCTS REF AA610680 LOT 8992985 IN OCTOBER 2023 AND THE EXPIRY DATE IS OCTOBER 2028. THE AA610680 LOT 8992985 HAS BEEN MANUFACTURED BY OUR TUNISIAN SITE .(INFORMED) CHECKING THE QUALITY DATABASES REVEALED A CONNECTION WITH THE DESCRIBED DEFECT WITH CAPA -000152.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND ONE OTHER COMPLAINT ON THE LOT N° 9445801. WE RECEIVED ONE USED SAMPLE WHICH WAS NOT COMPLETE. ONLY THE BODY PART WITH BALLOON WAS RECEIVED. THE VALVE PART OF THE DEVICE WAS NOT RETURNED. AS A RESULT, THE FUNCTIONALITY OF INFLATION/ DEFLATION BALLOON WITHOUT THIS PART CANNOT BE TESTED. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS CLOSELY MONITORED. A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME ITEM NUMBER AND SAME DEFECT OVER THE LAST FOUR YEARS: 5 SIMILAR CASES WERE FOUND. CAUSALITY ASSESSMENT: THE INCIDENT DESCRIBED AS CATHETER BALLOON DEFLATION BEING IMPOSSIBLE IS RELATED TO THE DEVICE. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED AND CONCLUDED 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 ADDITIONAL AVAILABLE INFORMATION, THE INDICATION FOR CATHETERIZATION WAS MAG3 SCINTIGRAPHY UNDER CATHETERIZATION. URINARY MEATUS WAS THE CHOSEN ROUTE OF CATHETERIZATION, AND THE BALLOON WAS NOT TESTED BEFORE INSERTION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON INFLATED TO THE VOLUME INDICATED BY THE MANUFACTURER. AT EXAMINATION IN THE HDJ NEPHROCARDIO DEPARTMENT, THE NURSE WAS UNABLE TO DEFLATE THE BALLOON TO REMOVE THE CATHETER. SEVERAL ATTEMPTS WITH 1ML, 2ML, 5ML AND 10ML SYRINGES. A NEW ATTEMPT TO DEFLATE THE BALLOON WITH A SYRINGE WITHOUT SUCCESS. THE SURGEON CUT THE CATHETER UPSTREAM OF THE BALLOON VALVE TO IRRIGATE THE BALLOON, WITHOUT SUCCESS. BLADDER ULTRASOUND PERFORMED IN EMERGENCY REVEALED THE BALLOON WAS STILL IN PLACE. DECISION TO STAY OVERNIGHT WITH SURGERY THE NEXT DAY. PATIENT RETURNED HOME THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497225 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9445801_AA61061002 03600040126844

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Unknown Required Intervention