BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT

    MDR report key: 20266311 · Received September 20, 2024

    Report

    Report Number
    9610711-2024-00248
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 1, 2024
    Report Date
    April 11, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    PMA / PMN Number
    K180469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED DATE..

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT REGARDING THE LOT NUMBER 9201966. CHECKING QUALITY DATABASE REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. ALL THE WORK ORDERS REGARDING THE MANUFACTURING OF THE JJ SILICONE HAVE BEEN CHECKED AND NO ANOMALY WAS DETECTED. IN JULY, WE RECEIVED 2 SEALED SAMPLES. THE 2 STENTS RECEIVED WERE BROWN IN COLOR, ESPECIALLY AT THE LEVEL OF THE PROXIMAL LOOP, AND NOT YELLOW AS NORMALLY FOR SILICONE STENT. THE BROWN COLOUR IS NOT UNIFORM OVER THE ENTIRE SURFACE OF THE STENT. DIFFERENT TESTS WERE REALIZED ON THE BROWN JJ. THE FIRST ONE WAS A SURFACE STUDY BY XPS (X-RAY PHOTOELECTRON SPECTROSCOPY) AND SHOWED AN EXCESSIVE AMOUNT OF CARBON ON THE SURFACE. IN A SECOND STEP, SOME MICROBIOLOGIC TESTS WERE PERFORMED TO IDENTIFY THE SOURCE OF CARBON. NO MICROBIOLOGICAL CONTAMINATION WAS FOUND. IN ADDITION, NO MAINTENANCE THAT COULD HAVE LED TO AN OIL LEAK (SOURCE OF CARBONE) BEFORE OR DURING THE PRODUCTION OF THESE BATCHES WAS MADE. DESPITE THE INVESTIGATIONS CARRIED OUT ON THESE SAMPLES, THE SOURCE OF CARBON CONTAMINATION POTENTIALLY RESPONSIBLE FOR THE COLOR CHANGE COULD NOT BE IDENTIFIED. WE ARE NOT ABLE TO IDENTIFY ANY ROOT CAUSE EXPLAINING THIS CHANGE OF COLOR.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE KIT WAS OPENED, THE DOCTOR FOUND THERE WAS A STRANGE COLOR ON THE STENT ITSELF INSIDE THE PLASTIC & STERILE PACK.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE KIT WAS OPENED, THE DOCTOR FOUND THERE WAS A STRANGE COLOR ON THE STENT ITSELF INSIDE THE PLASTIC & STERILE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354001 IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE FAD COLOPLAST A/S 9201966_BCHS641002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown