BEUDAMED
    FDA Adverse Event Other Summary report: N

    BECKER 5MM X 32CM LARGE HANDLE CANNULA

    MDR report key: 2171915 · Received June 21, 2006

    Report

    Report Number
    2025576-2006-00002
    Event Type
    Other
    Date Received
    June 21, 2006
    Date of Event
    February 17, 2006
    Report Date
    June 15, 2006
    Manufacturer
    BYRON MEDICAL
    Product Code
    GEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CANNULA WAS RECEIVED FROM THE CUSTOMER WITH THE TIP DETACHED FROM THE LUMEN. THE LUMEN IS BENT WITH A TOTAL T.I.R OVER 3/4" INDICATING TOO MUCH FORCE WAS USED. THE HANDLE APPEARS TO HAVE BEEN HEAVILY USED. IT IS DISCOLORED AND HAS WHAT APPEAR TO BE SPOTS AT ALMOST 90 DEGREES OUT FROM THE LUMEN. ONE OF THE TINES WAS BENT OUTWARD AT APPROX 45 DEGREES. THE CANNULA WAS MEASURED AND MADE TO SPECS.

    Description of Event or Problem · 1

    CANNULA BROKE OFF IN TWO PIECES WHILE BEING USED IN A CASE. THE SURGEON WAS ABLE TO RETRIEVE THE TIP FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKER 5MM X 32CM LARGE HANDLE CANNULA CANNULA GEA BYRON MEDICAL BEC532L LST

    Patients

    Seq Age Sex Outcome Treatment
    1 Other