BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER

    MDR report key: 20321965 · Received September 27, 2024

    Report

    Report Number
    9610711-2024-00263
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 1, 2024
    Report Date
    March 10, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    LJE
    UDI-DI
    03600040257814
    PMA / PMN Number
    K211911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE COMPLAINT HISTORY DATABASE, REVEALED NO TRENDS FOR THE LOT NUMBER 9885816. IN END OF OCTOBER, WE RECEIVED SEALED SAMPLES OF LOT 9885816: THE FUNCTIONALITY OF THE SAMPLES WAS TESTED AND REVEALED 3 NON-COMPLIANT DEVICES, A SOCK EFFECT WAS OBSERVED. THESE 3 DEFECTIVE PRODUCTS WERE MANUFACTURED USING AN INTERMEDIATE J CATHETER WITH LOT NUMBER 9063083. OTHER J CATHETER INTERMEDIATE LOT WAS TESTED AND CONFORMED (9350425*3. 9063082*4; 9063083*13). ACCORDING TO THE INFORMATION KNOWN QUALITY DATABASE WAS CHECKED AND REVEALED ONE NON-CONFORMITY OPENED ON OCTOBER 2024: NC-009074 "MANDRIN STUCK IN THE VORTEK J CATHETER" POTENTIALLY RELATED TO THE COMPLAINT'S DESCRIPTION. THE ROOT CAUSE ANALYSIS IS ONGOING AT THIS TIME AND ACTIONS WILL FOLLOW THE RESULTS OF THIS ANALYSIS. A SIMILAR CASE STUDY WAS PERFORMED BASED ON PCN SET PRODUCT, SAME DEFECT: FUNCTIONALITY MANDRIN STUCK FROM OCTOBER 2020 TO OCTOBER 2024:11 SIMILAR CASE WERE FOUND. (SEE DOCUMENT IN ATTACHMENT). THE EVALUATION HAS SHOWED THAT 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.

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE MANDREL CANNOT BE REMOVED AND THE DILATORS BEND. THERE IS A HIGH RISK OF KIDNEY DAMAGE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE MANDREL CANNOT BE REMOVED AND THE DILATORS BEND. THERE IS A HIGH RISK OF KIDNEY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492230 VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE LJE COLOPLAST A/S 9885816_RJA1141002 03600040257814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown