BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPAN UTM

    MDR report key: 10122402 · Received June 5, 2020

    Report

    Report Number
    3002444944-2020-00002
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    April 19, 2020
    Report Date
    May 8, 2020
    Manufacturer
    COPAN ITALIA SPA
    Product Code
    JSM
    PMA / PMN Number
    K042970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION WAS CARRIED OUT ON: DOCUMENTAL REVIEW: THE BHR LOT# 200469000 (35750 PIECES) HAS BEEN EXAMINED AND NO DEVIATION HAVE BEEN FOUND. THIS IS THE FIRST EVENT RECEIVED ON THIS LOT; STERILIZATION PROCESS REVIEW: DOCUMENTATION RELATED TO STERILIZATION PROCESS HAS BEEN EXAMINED AND NO ANOMALIES LINKED TO THE REPORTED ISSUE HAVE BEEN DETECTED; RETAINS INSPECTIONS: VISUAL INSPECTION AND MECHANICAL TESTS WERE PERFORMED ON COPAN'S RETAINS ACCORDING TO THE INTERNAL OPERATIVE PROCEDURE. THE TESTS DIDN'T SHOW ANOMALIES: THE STICKS APPEARED INTACT AND RESISTANT; NO BREAKAGES SIGNALS HAVE BEEN FOUND. CONSIDERING THE BHR REVIEW AND THE TESTS PERFORMED ON RETAINS, THE INTERNAL INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTION OR DEFECT IN THE DEVICE LOTS ASSOCIATED WITH THIS INCIDENT. AN ANALYSIS OF THE INCIDENCE OF THE PROBLEM (SWAB BREAKAGE DURING COLLECTION) HAS BEEN PERFORMED FROM 2016 UP TO MAY 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.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). ON 8TH MAY 2020 COPAN RECEIVED AN EMAIL FROM ITS LOCAL DISTRIBUTOR INFORMING THAT "SWAB TIP DETACHED DURING PROCEDURE AT ROYAL MELBOURNE HOSPITAL", PROVIDING PICTURES OF THE BROKEN SWAB AND A FORM IN WHICH THE USER DECLARES "TIP OF FLOQSWAB CAME OFF IN THE PATIENTS NASOPHARYNX REQUIRING A SURGICAL INTERVENTION TO REMOVE". THE PICTURES SHOWED THAT THE SWAB BROKE AT THE FIRST DIAMETER CHANGE FROM THE TIP. THE DISTRIBUTOR INFORMED THAT THE LOT #2003518 OF PRODUCT A305CS01 WAS INVOLVED. THE SWAB WAS A COMPONENT OF THE PRODUCT UTM KIT MADE BY COPAN (CATALOG# 360C , LOT #200469000). ON (B)(6), THE HOSPITAL ANSWERED TO SOME QUESTIONS SUBMITTED ON (B)(4) BY COPAN THROUGH THE DISTRIBUTOR IN WHICH THE NURSE PROVIDE ADDITIONAL INFORMATION ON THE EVENT. ON 21ST MAY, COPAN RECEIVED BACK A FORM FILLED BY THE DOCTOR WHO COLLECTED THE SAMPLE FROM THE PATIENT ANSWERING TO SOME CLARIFICATIONS REQUESTED BY COPAN. THE FOLLOWING INFORMATION WAS RETRIEVED: THE SWAB BROKE DURING NASOPHARYNGEAL COLLECTION PROCEDURE FOR COVID DETECTION. THE SWAB WAS USED FIRST FOR AN ORAL COLLECTION AND AFTER FOR THE NASOPHARYNGEAL COLLECTION. AT THE TIME OF THE COLLECTION, THE PATIENT WAS HOSPITALIZED, UNDER GENERAL ANAESTHESIA (SEDATED AND INTUBATED). THE HOSPITALIZATION WAS NOT A RESULT OF THE BROKEN SWAB AND IT WAS NOT PROLONGED BY THE INCIDENT. A VISUAL INSPECTION OF AIRWAYS WAS PERFORMED BEFORE THE COLLECTION TO EXCLUDE OBSTACLES. NO SHAPING OF THE SWAB WAS DONE BEFORE THE COLLECTION. THE BREAK OF THE SWAB CAUSED A SMALL AMOUNT OF NASAL BLOOD. A NASOENDOSCOPY WAS PERFORMED TO FIND THE BROKEN PIECE. THE BROKEN PIECE WAS NOT FOUND. THE DOCTOR HAD FOLLOW-UP WITH THE PATIENT AND FREQUENT SCREENING FOR FOREIGN BODY SYMPTOMS. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED BY THE DOCTOR AS A CONSEQUENCE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587664 COPAN UTM UNIVERSAL TRANSPORT MEDIUM SYSTEM (UTM-RT) JSM COPAN ITALIA SPA 360C 200469000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention