BEUDAMED
    FDA Adverse Event Other Summary report: N

    BYRON CANDY CANE CANNULA

    MDR report key: 645718 · Received November 8, 2005

    Report

    Report Number
    2025576-2005-00001
    Event Type
    Other
    Date Received
    November 8, 2005
    Date of Event
    October 11, 2005
    Report Date
    October 17, 2005
    Manufacturer
    BYRON MEDICAL
    Product Code
    GDM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A ONE INCH PIECE OF CANNULA TIP BROKE OFF IN A PT DURING A PROCEDURE. THE DOCTOR WANTED THE PT TO HEAL FOR A MONTH, THEN HAVE HER X-RAYED TO DETERMINE THE EXACT LOCATION OF THE TIP FOR RETRIEVAL. UNTIL THEN THE REMAINING PORTION OF THE CANNULA WAS TO BE RETURNED FOR EVALUATION. ONCE THE TIP IS REMOVED IT IS TO BE RETURNED ALSO. THE DOCTORS OFFICE CALLED IN 2005 TO SAY THE PT DOES NOT WANT THE DOCTOR TO REMOVE THE TIP AND WILL SEEK ANOTHER FACILITY TO HAVE THE PIECE REMOVED. AS OF THIS REPORT THE CO WILL NOT RECEIVE ANY PIECES TO EVALUATE UNTIL FURTHER NOTICE FROM THE DOCTORS OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BYRON CANDY CANE CANNULA ASPIRATION CANNULA GDM BYRON MEDICAL CCC 426L LST

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention