BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPAN UTM

    MDR report key: 10123020 · Received June 5, 2020

    Report

    Report Number
    3002444944-2020-00003
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    April 29, 2020
    Report Date
    May 7, 2020
    Manufacturer
    COPAN ITALIA SPA
    Product Code
    JSM
    PMA / PMN Number
    K042970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE LOT # 200517801 OF MODEL # 360C THE FOLLOWING ANALYSIS HAVE BEEN PERFORMED: BATCH HISTORY RECORD REVIEW: ALL THE PRODUCTION STEPS RELATED TO THE CLAIMED PRODUCT (CATALOGUE # 360C, LOT # 200517801) HAVE BEEN ANALYSED AND NO DEVIATIONS/ANNOTATIONS LINKED TO THE REPORTED ISSUE HAVE BEEN DETECTED; STERILIZATION PROCESS REVIEW: THE DOCUMENTATION RELATED TO THE STERILIZATION PROCESS HAS BEEN EXAMINED AND NO ANOMALIES LINKED TO THE REPORTED ISSUE HAVE BEEN DETECTED; RETAINS INSPECTIONS: THE VISUAL INSPECTION AND THE MECHANICAL VERIFICATION WERE PERFORMED ON COPAN'S RETAINS ACCORDING TO THE INTERNAL OPERATIVE PROCEDURE. THE TESTS DIDN'T SHOW ANOMALIES: THE STICKS APPEARED INTACT AND RESISTANT AD NO BREAKAGES SIGNALS HAVE BEEN FOUND; THE ANALYSIS OF HISTORICAL DATA DIDN'T SHOW OTHER COMPLAINTS OF THE SAME TYPE ASSOCIATED TO THE LOT # 200517801 WHICH WAS SOLD TO SEVERAL CUSTOMERS IN DIFFERENT COUNTRIES. CONSIDERING THE BHR REVIEW AND THE TESTS PERFORMED ON RETAINS, THE INTERNAL INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTION OR DEFECT IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. AN ANALYSIS OF THE INCIDENCE OF THE PROBLEM (SWAB BREAKAGE DURING COLLECTION) HAS BEEN PERFORMED FROM 2016 UP TO (B)(6) 2020. CONSIDERING THE COMPLAINTS RECEIVED AND THE VOLUME OF PIECES SOLD WORLDWIDE FOR ALL THE PRODUCT CODES HAVING THE SAME SWAB GEOMETRY, THE FAILURE INCIDENCE IS 1.6 IN 10 MILLION. CONSIDERING THAT TO OUR KNOWLEDGE NO EVENT HAS LED TO SERIOUS MEDICAL CONSEQUENCES SO FAR IN SIMILAR CIRCUMSTANCES (BREAKAGE OF THE SWAB DURING COLLECTION), THAT THE FAILURE RATE IS VERY LOW, THAT THE SWAB BREAKAGE HAS BEEN ALREADY EVALUATED IN THE RISK ANALYSIS OF THE PRODUCT, NO FURTHER ACTION IS PLANNED AT THIS TIME. COPAN WILL CONTINUE TO MONITOR PRODUCTS FOR SIMILAR EVENTS AND WILL REOPEN THE ASSESSMENT OF THIS COMPLAINT IF ADDITIONAL INFORMATION WILL BE RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE EVENT OCCURED IN (B)(6). ON (B)(6) 2020 COPAN RECEIVED A COMPLAINT FROM THE LOCAL DISTRIBUTOR ABOUT A SWAB THAT BROKE IN THE NOSE OF A PATIENT AT A CHANGE DIAMETER AS A FIRST CASE. THE EVENT HAS BEEN DESCRIBED AS FOLLOW: "L'ÉCOUVILLON S'EST CASSÉ AU NIVEAU DE LA JOINTURE DANS LE NEZ D'UN PATIENT. A CE JOUR, AUCUN AUTRE INCIDENT N'EST SURVENU." THE CLAIMED CATALOGUE # WAS 518CS01?. FOLLOWING TRACEABILITY ANALYSIS BETWEEN DISTRIBUTOR AND USER, THE DISTRIBUTOR INFORMED US THAT THE COMPLAINT IS RELATED TO THE SWAB INCLUDED IN THE UTM KIT CATALOGUE # 360C, LOT # 200517801. ON (B)(6) 2020 COPAN SENT A QUESTIONAIRE TO FUTHER INVESTIGATE THE INCIDENT. 3 ATTEMPTS WERE MADE BY COPAN TO OBTAIN MORE INFORMATION. UP TO DATE THE ONLY PIECE OF INFORMATION RECEIVED IS: THE BROKEN PIECE REMAINED IN THE NOSE. A DOCTOR WAS CALLED TO REMOVE THE PIECE USING SPECIFIC FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587162 COPAN UTM UNIVERSAL TRANSPORT MEDIUM SYSTEM (UTM-RT) JSM COPAN ITALIA SPA 360C 200517801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention