BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER 4MM X 26CM LARGE HANDLE CANNULA

    MDR report key: 800926 · Received December 20, 2006

    Report

    Report Number
    2025576-2006-00006
    Event Type
    Malfunction
    Date Received
    December 20, 2006
    Date of Event
    November 27, 2006
    Report Date
    November 27, 2006
    Manufacturer
    BYRON MEDICAL
    Product Code
    MUU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH THE TIP BROKEN OFF. THE THREE TINES ON THE TIP HAVE BEEN BENT OUT AND THEN BENT BACK INWARD. THE REMAINING TINES ON THE CANNULA WERE ALL BENT OUTWARD. THE BEND ANGLES ON THE CANNULA WERE NOT CONSISTENT WITH HOW THE TIP WAS RECEIVED INDICATING THE TIP OR THE CANNULA MIGHT HAVE BEEN MANIPULATED IN SOME WAY.

    Description of Event or Problem · 1

    PER THE REPORT FROM THE CUSTOMER: APPROXIMATELY 5 MINUTES INTO THE PROCEDURE THE DR. REALIZED THE TIP OF THE CANNULA WAS MISSING. THE TIP WAS FOUND INSIDE THE PATIENT AFTER SEARCHING FOR 10-15 MINUTES. THE CUSTOMER WAS UNABLE TO PROVIDE A LOT NUMBER FOR THE BROKEN CANNULA OR THE DATE THEY RECEIVED THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKER 4MM X 26CM LARGE HANDLE CANNULA LIPOSUCTION CANNULA MUU BYRON MEDICAL BEC426L LST

    Patients

    Seq Age Sex Outcome Treatment
    1 YR