BEUDAMED
    FDA Adverse Event Other Summary report: N

    COPAN VENTURI TRANSYSTEM

    MDR report key: 2845140 · Received November 1, 2012

    Report

    Report Number
    3002444944-2012-00001
    Event Type
    Other
    Date Received
    November 1, 2012
    Date of Event
    January 1, 2011
    Report Date
    September 6, 2011
    Manufacturer
    COPAN ITALIA S.P.A.
    Product Code
    JSL
    PMA / PMN Number
    K972448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER INVESTIGATION REPORT: OUR ORIGINAL COMPLAINT INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTION OR DEFECT IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. THE DHR WAS REVIEWED AND NO ANOMALIES HAVE BEEN FOUND DURING ALL THE PRODUCTION STEPS OF THE DIFFERENT PRODUCT COMPONENTS. THE TEST PERFORMED ON THE RETAINED SAMPLE FROM THE CLAIMED LOT WAS DONE FOLLOWING INTERNAL SOP FOR MECHANICAL RESISTANCE TEST. ALL THE TESTED SWABS GAVE RESULTS WITHIN THE ACCEPTABILITY LIMITS. (NOTE: THE SAMPLES TESTED WERE COMING FROM THE SAME LARGE LOT NUMBER BUT NOT THE SAME BATCH NUMBER). AS RESULTS OF FDA INSPECTION, COPAN (B)(4) HAS REVIEWED IT'S CRITERIA FOR A REPORTABLE EVENT AND HAS REVIEWED COMPLAINTS FROM 2011 AND 2012 TO IDENTIFY REPORTABLE EVENTS UNDER THE REVISED REPORTING CRITERIA.

    Description of Event or Problem · 1

    THE EVENT HAPPENED IN (B)(6). "WE HAVE A REPORTED INCIDENT WHERE THE COTTON BUD BECAME DETACHED FROM THE SHAFT OF A SWAB (108 CF.FR), WHILE A DOCTOR WAS SWABBING THE THROAT OF A (B)(6) CHILD. IT WAS RECOVERED SATISFACTORILY, BUT THERE WAS SOME PT DISTRESS UNDERSTANDABLY. NO ABNORMALITY WAS NOTED WITH THE SWAB PRIOR TO USE. THE SWAB WAS IN THE CHILD'S MOUTH FOR "HALF A SECOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COPAN VENTURI TRANSYSTEM JSL COPAN ITALIA S.P.A. 108CF.FR TUSA00

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other