BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER

    MDR report key: 21060421 · Received January 2, 2025

    Report

    Report Number
    9610711-2025-00003
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 9, 2024
    Report Date
    April 11, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    LJE
    PMA / PMN Number
    K211911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 9758389. THIS PRODUCT WAS A KIT. IT WAS COMPOSED WITH FOLLOWING COMPONENTS: GUIDEWIRE: ITEM NUMBER: SQ224690, LOT NUMBER: 9756599, 9756600, CHIBA NEEDLE 22G: ITEM NUMBER: SS720190, LOT NUMBER: 9772279, 9772280, CHIBA NEEDLE 18G: ITEM NUMBER: SS720390, LOT NUMBER: 9803848, DILATOR CH06/08/10: ITEM NUMBER: YD250190, LOT NUMBER: 9772292, J CATHETER: ITEM NUMBER: YJ160890, LOT NUMBER: 9772267, 9772270, THIS ISSUE DESCRIBE CONCERNED THE J CATHETER. A BROKEN METALLIC MANDREL CAN OCCUR WHEN THE METAL STYLET GETS STUCK DURING THE PROCEDURE AND DOESN'T COME OUT OF THE CATHETER OR COMES OUT WITH DIFFICULTLY. THE QUALITY DATABASE WAS CHECKED AND REVEALED ONE CORRECTIVE AND PREVENTIVE ACTION FOR "MANDREL BLOCKED IN YJ16XX". 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 THE PRODUCT AND SAME DEFECT (FUNCTIONALITY MANDRIN STUCK) FROM DECEMBER 2020 TO DECEMBER 2024: 21 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 STYLET WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910499 VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE LJE COLOPLAST A/S 9888562_RJA1081002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown