BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPAN ESWAB

    MDR report key: 4411659 · Received January 7, 2015

    Report

    Report Number
    3002444944-2015-00001
    Event Type
    Injury
    Date Received
    January 7, 2015
    Date of Event
    December 2, 2014
    Report Date
    December 8, 2014
    Manufacturer
    COPAN ITALIA S.P.A
    Product Code
    JTW
    PMA / PMN Number
    K061301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF DHR: COPAN CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS BEFORE THE RELEASE ON THE MARKET OF THE SWABS OF THE PRODUCT CODE 480C LOT NUMBER NI2I00. NO ANOMALIES HAVE BEEN FOUND: LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. SINCE THE INVOLVED DEVICE WAS NOT RETURNED TO COPAN FOR EVALUATION, AN INVESTIGATION ANALYSIS HAS BEEN PERFORMED ON THE RETAINED SAMPLES OF THE CLAIMED LOT. A MECHANICAL SWAB SHAFT BENDING TEST HAS BEEN CARRIED OUT. ALL THE SWABS SUBJECTED TO THE BENDING TEST GAVE CONFORMING RESULTS. THE VISUAL CONTROL OF THE SHAFT DID NOT SHOW ANY ANOMALIES. CONSIDERING THE RESULTS OF OUR INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. IN FACT, THE INTERNAL INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTION OR DEFECT IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. (B)(4).

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION PROVIDED INDICATES THAT DURING COLLECTION OF ROUTINE THROAT CULTURE FROM ADULT PT BY AN EXPERIENCED ER STAFF MEMBER, USING THE ESWAB COLLECTION AND PRESERVATION SWAB (COPAN BRAND) FOR STREP THROAT CULTURE, THE SWAB BROKE IN CORRESPONDENCE OF ITS BREAKING POINT INSIDE THE PT'S MOUTH, LEAVING THE PLASTIC PIECE INSIDE HER THROAT/AIRWAY. IT WAS REPORTED THAT THE PT WAS COLLABORATIVE AND THAT THE PIECE WAS MANUALLY RETRIEVED FROM PT'S MOUTH. THE BROKEN PIECE WAS AT THE SOFT PALATE. THE PIECE WAS SUCCESSFULLY REMOVED. THERE ARE NO ADVERSE EFFECTS ON THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12864 COPAN ESWAB TRANSPORT CULTURE MEDIUM DEVICE ; JTX JTW COPAN ITALIA S.P.A 480C NI2I00

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention