BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMOR STENT DOUBLE LOOP URETERAL STENT KIT

    MDR report key: 20310821 · Received September 26, 2024

    Report

    Report Number
    9610711-2024-00258
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 1, 2024
    Report Date
    February 20, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    UDI-DI
    03600040943717
    PMA / PMN Number
    K213186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINT REGARDING THE LOT NUMBER 9841032. IN SEPTEMBER, WE RECEIVED SOME EMPTY PACKAGING: PACKAGING OF THE STENT: REFERENCE: YCV974 LOT NUMBER 9644521 WITH THE KIT LABEL : BCCG74 LOT NUMBER 9841032. PACKAGING OF THE PUSHER: YN2876 LOT NUMBER 9735725. THE PACKAGING RECEIVED CORRESPONDED WELL TO THE COMPLAINT RECEIVED, A PUSHER YN2876 WAS IN THE KIT INSTEAD OF A PUSHER YN2879. SO THE PUSHER INCLUDES IN THIS KIT DOES NOT CORRESPOND TO THE EXPECTED REFERENCE. OUR DISTRIBUTION CENTER IN LE PLESSIS PATÉ WAS INFORMED ABOUT THIS COMPLAINT, AS THEY ARE RESPONSBLE OF THE KITTING PROCESS. THE INVESTIGATION SHOWED A KITTING ERROR, MADE BY AN OPERATOR WHO DID NOT PERFORM THE 100% CHECK OF THE COMPONENTS AND THE LOT NUMBERS. AS NO OTHER COMPLAINT RECEIVED, THE EMPTY CHAIN WAS ALSO NOT PROBABLY DONE, WHICH CAN EXPLAIN THE PRESENCE ON ANOTHER PUSHER REFERENCE IN THE KIT AND NO OTHER COMPLAINT RECEIVED. A RETRAINING TO THE PROCEDURE WAS PERFORMED TO THE OPERATOR AND THE ADDITION OF A STEP FOR "EMPTY CHAIN" WAS ADDED IN THE WORK ORDERS. A HEALTH HAZARD EVALUATION (HHE) WAS PERFORMED REGARDING THIS COMPLAINT (HHE - WRONG PUSHER IN TUMORSTENT KITS - VV-0625844). IN THE CONTEXT OF THIS HHE, A CLINICAL ASSESSMENT AND A RMF EVALUATION WERE PERFORMED: CONCLUSION OF THE CLINICAL ASSESSMENT: THE WRONG DEVICE CONTAINED IN THE PEEL POUCH IS CLEARLY LABELLED AND THE DISCREPANCY WITH THE BOX LABEL SHOULD NOT BE IGNORED. EVEN THOUGH THE DIFFERENCE IS IGNORED, THE SIZE OF THE PUSHER (CH6 INSTEAD OF CH7.5) IS NOT COMPATIBLE WITH THE VORTEK TUMOR STENT PROVIDED IN THE KIT (CH7) LEADING TO THE NEED TO CHANGE THE DEVICE (PROLONGED PROCEDURE) DUE TO THE IMPOSSIBILITY TO CONNECT CORRECTLY THE PUSHER TO THE URETERAL STENT (MAX EXTERNAL DIAMETER ORX PUSHER CH6 = 1.25 MM; MIN INTERNAL DIAMETER TUMOR STENT = 1.40 MM). THE HARM PROLONGED PROCEDURE ASSOCIATED TO THIS INCIDENT IS MINIMAL (SEVERITY LEVEL 2, P2=5). CONCLUSION OF THE RMF EVALUATION BASED ON CRIQ 244: RISK IDENTIFIED 10201 (HAZARDOUS SITUATION:INCONSISTENT LABELING /LABELING DOES NOT MATCH PRODUCT-DIMENSION PROBLEM I.E:4,8CH INSTEAD OF 6CH)OR PRODUCT LINE (I.E:SILICONE VS BIOSOFT). 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. THE HARMS, SEVERITY AND OCCURRENCE ARE ALL WITHIN ANTICIPATED LEVELS PER THE RISK DOCUMENTATION. THE FOLLOW-UP OF THIS HHE WILL BE DONE THROUGH THE MONTHLY PRODUCT REVIEW AND THIS HHE WILL BE REVISED IF NEW COMPLAINTS ARE RECEIVED FROM THE MARKET, WHEREBY INFORMING US THAT PRODUCTS HAVE BEEN USED RESULTING IN NEW CLINICAL AND RISK EVALUATION. NO FURTHER ACTION ON THE MARKET WILL BE CONDUCTED ON THESE LOT NUMBERS. ACCORDING TO THE INVESTIGATION PERFORMED, QUALITY DATABASE WAS CHECKED AND REVEALED ONE CORRECTIVE AND PREVENTIVE ACTION IN RELATION TO THE DESCRIBE DEFECT: CAPA-000213 " WRONG COMPOSITION OF KIT LEADING TO MISLABELLING" OPENED IN FEBRUARY 2024. THE ACTIONS CONCERN IMPROVEMENTS ON THE KITTING PROCESS. THE VERIFICATION OF THE ACTIONS EFFECTIVENESS IS ONGOING. NO NEW COMPLAINT OF KITTING ERROR WAS RECEIVED SINCE THE IMPLEMENTATION OF THE ACTIONS. A SIMILAR CASE STUDY WAS PERFORMED BASED ON FAMILY PRODUCT VORTEK® , VORTEK® HYDRO-COATED / DEFECT: WRONG PRODUCT PACKAGED FROM OCTOBER 2020 TO OCTOBER 2024: 12 SIMILAR CASES WERE FOUND.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE BOX IS SUPPOSED TO CONTAIN THE TUMOR STENT AND A PUSHER CH/FR 7.5. CONTAINED IN THE BOX WAS TUMOR STENT CH/FR 7 AND A PUSHER CH/FR 6 (INSTEAD OF CH/FR 7.5) MAKING THE USE OF THE PUSHER IMPOSSIBLE REQUIRING THE USE OF ANOTHER PUSHER OF THE CORRECT SIZE CH/FR 7.5.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE BOX IS SUPPOSED TO CONTAIN THE TUMOR STENT AND A PUSHER CH/FR 7.5. CONTAINED IN THE BOX WAS TUMOR STENT CH/FR 7 AND A PUSHER CH/FR 6 (INSTEAD OF CH/FR 7.5) MAKING THE USE OF THE PUSHER IMPOSSIBLE REQUIRING THE USE OF ANOTHER PUSHER OF THE CORRECT SIZE CH/FR 7.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239722 TUMOR STENT DOUBLE LOOP URETERAL STENT KIT UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE FAD COLOPLAST A/S 9841032_BCCG744002 03600040943717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown