BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR III 3MM X 15CM CANNULA, SMALL HAN

    MDR report key: 739667 · Received July 17, 2006

    Report

    Report Number
    2025576-2006-00005
    Event Type
    Malfunction
    Date Received
    July 17, 2006
    Report Date
    June 16, 2006
    Manufacturer
    BYRON MEDICAL
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE CANNULA WAS PERFORMED. THE CANNULA LUMEN WAS FOUND TO BE BENT APPROXIMATELY 0.500 TOTAL INDICATOR READING. THE WELDED TIP OF THE CANNULA WAS MISSING AND APPEARED TO HAVE BEEN A CLEAN BREAK EITHER AT OR JUST BELOW TO WELD JUNCTION. THE CAUSE OF THE BREAK COULD NOT BE DETERMINED AT THE TIME OF THE EVALUATION.

    Description of Event or Problem · 1

    PER THE MENTOR REP, THE TIP OF THE CANNULA HAS BROKEN OFF. THERE IS A POSSIBILITY THAT THE TIP IS STILL INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCELERATOR III 3MM X 15CM CANNULA, SMALL HAN ASPIRATION CANNULA GAA BYRON MEDICAL III-315S LST

    Patients

    Seq Age Sex Outcome Treatment
    1 *