BEUDAMED
    FDA Adverse Event Other Summary report: N

    MLADICK CURVED CANNULA 4MM X 26CM

    MDR report key: 732182 · Received June 29, 2006

    Report

    Report Number
    2025576-2006-00003
    Event Type
    Other
    Date Received
    June 29, 2006
    Date of Event
    January 30, 2006
    Report Date
    January 30, 2006
    Manufacturer
    BYRON MEDICAL
    Product Code
    GDM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE CANNULA, A VISUAL INSPECTION WAS PERFORMED. THE CANNULA (LUMEN) BROKE APPROX 10MM FROM THE HANDLE. THE CAUSE OF BREAK COULD NOT BE DETERMINED AT THE TIME OF INSPECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS CANNULA BROKE IN HALF WHILE IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MLADICK CURVED CANNULA 4MM X 26CM ASPIRATION CANNULA GDM BYRON MEDICAL MCLVX-326L LST

    Patients

    Seq Age Sex Outcome Treatment
    1 *