BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER

    MDR report key: 20351292 · Received October 2, 2024

    Report

    Report Number
    9610711-2024-00270
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 1, 2024
    Report Date
    April 1, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE COMPLAINT HISTORY DATABASE, REVEALED NO TRENDS FOR THE LOT NUMBER 9862465. IN (B)(6) 2024, WE RECEIVED SEALED SAMPLES FROM LOT 9862465: THE FUNCTIONALITY OF THE SAMPLES WAS TESTED AND REVEALED 2 NON-COMPLIANT DEVICES, A SOCK EFFECT WAS OBSERVED. THESE 2 DEFECTIVE PRODUCTS WERE MANUFACTURED USING AN INTERMEDIATE BATCH NUMBER OF J CATHETER LOT 9063083. ACCORDING TO THE INFORMATION KNOWN QUALITY DATABASE WAS CHECKED AND REVEALED ONE NON-CONFORMITY OPENED ON (B)(6) 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 PRODUCT , SAME DEFECT: FUNCTIONALITY MANDRIN STUCK FROM (B)(6) 2024:19 SIMILAR CASE WERE FOUND. (SEE DOCUMENT IN ATTACHMENT). A RMF EVALUATION WAS PERFORMED BASED ON CRIQ209 - RISKS IDENTIFIED 13270 (HAZARDOUS SITUATION: CATHETER IS NOT CORRECTLY POSITIONED). 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.

    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
    1916618 VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE LJE COLOPLAST A/S 9862465_RJA1141002 03600040257814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown