BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL CULTURESWAB PLUS AMIES GEL WITHOUT CHARCO

    MDR report key: 921761 · Received March 28, 2007

    Report

    Report Number
    1119779-2007-00005
    Event Type
    Malfunction
    Date Received
    March 28, 2007
    Date of Event
    March 2, 2007
    Manufacturer
    COPAN ITALIA
    Product Code
    LIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS FOR THIS LOT OF MATERIAL WERE EXAMINED AND SHOWED NO ANOMALIES DURING MANUFACTURER OF THIS PRODUCT. A 100% VISUAL INSPECTION WAS CONDUCTED PRIOR TO BULK PACKAGING. RETENTION SAMPLES OF THIS LOT WERE VISUALLY EXAMINED FOR MISSING TIPS. SAMPLES OF THIS LOT WERE ALSO RETESTED USING A WETABILITY AND MANUAL PULL TEST TO ASSURE NO DETACHMENT OF THE SWABS FROM THE SHAFT. ALL RESULTS WERE ACCEPTABLE. BASED ON PRODUCT TRENDING AND INVESTIGATION RESULTS, THIS APPEARS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO REPORT THAT WHILE CULTURING A PATIENT'S INCISION IN THE OPERATING ROOM (OR), THE OR NOTICED THAT ONE OF THE RAYON TIPS (THIS SWAB HAS TWO TIPS) WAS MISSING WHEN THEY WERE REPLACING THE SWAB BACK INTO THE TRANSPORT TUBE. THE SURGEONS CONDUCTED A THOROUGH SEARCH OF THE PATIENT'S INCISION AND FAILED TO FIND THE RAYON TOP AND THEY DO NOT BELIEVE THE TIP WAS LEFT IN THE INCISION. THE TIP WAS NEVER LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL CULTURESWAB PLUS AMIES GEL WITHOUT CHARCO LIO LIO COPAN ITALIA NA 8K7200

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other