BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSOFT DUO DOUBLE LOOP URETERAL STENT KIT

    MDR report key: 20311505 · Received September 26, 2024

    Report

    Report Number
    9610711-2024-00261
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 1, 2024
    Report Date
    March 12, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    PMA / PMN Number
    K170422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INFORMATIONS KNOWN A TRACEABILITY WAS PERFORMED BASED ON THESE TWO LOT NUMBER MENTIONED ON THE COMPLAINT. FIRST LOT NUMBER: 9539003 THIS PUSHER YN287691 WAS USED IN DIFFERENT KIT REFERENCE, BUT NONE ON THE THREE REFERENCE MENTIONED ON THE COMPLAINT. SECOND LOT NUMBER: 9668242; THIS LOT OF PUSHER YN287691 WAS USED IN DIFFERENT KIT REFERENCE INCLUDING REFERENCES (B)(4) LOT NUMBER 9823736 & (B)(4) LOT NUMBER 9822270. WITH THE HELP OF THE PACKAGING MANAGER, THESE TWO LABELS WERE REPRINTED AND SEND TO THE HOSPITAL FOR TEST: HOSPITAL CONFIRMED THAT INFORMATION PROVIDED BY DATA MATRIX WERE CONFORMED TO OUR PRODUCTS. AT THE SAME TIME, THE GTIN AND QR CODE CORRESPONDENCE WAS CHECKED BY THE SUPPLY CHAIN, AND NO DEFECTS WERE FOUND. NO OTHER COMPLAINT WAS REGISTERED ON THESE LOT NUMBER ABOUT THIS ISSUE. DESPITE INVESTIGATION PERFORMED NO ROOT CAUSE WAS DEFINE BUT WE ASSUME THAT THE PROBLEM IS NOT DUE TO MANUFACTURING, AS THE LABELS WERE COMPLIANT. ACCORDING TO THE INFORMATIONS KNOWN QUALITY DATABASE WAS CHECKED AND REVEALED NO ANOMALY REGISTERED IN RELATION TO THE DESCRIBE DEFECT.

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN SCANNING THE QR CODE ON THE PACKAGING, THE REFERENCE (B)(4) WAS DISPLAYED. BUT THE CORRECT REFERENCES ORDERED (B)(4) ARE INDICATED ON THE LABELS. DIFFERENT PRODUCTS IN STOCK WERE USED ON DIFFERENT PATIENTS.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN SCANNING THE QR CODE ON THE PACKAGING, THE REFERENCE BCAG64 WAS DISPLAYED. BUT THE CORRECT REFERENCES ORDERED (BCAGD5 AND BCAGE5) ARE INDICATED ON THE LABELS. DIFFERENT PRODUCTS IN STOCK WERE USED ON DIFFERENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233804 BIOSOFT DUO DOUBLE LOOP URETERAL STENT KIT UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE FAD COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown