BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINESSE ULTRA

    MDR report key: 1905401 · Received November 18, 2010

    Report

    Report Number
    1905401
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BARD
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN ULTRASOUND OF THE RIGHT BREAST WITH A BIOPSY WITH CLIP AND MAMMOGRAPHY. THIS PATIENT WEARS A BACK BRACE DUE TO A RECENT SPINAL FUSION AND THE BRACE WAS REMOVED FOR THE PROCEDURE WITH THE PATIENT'S PERMISSION. DURING THE PROCEDURE, THE VACUUM ASSIST BIOPSY DEVICE MALFUNCTIONED (THE NEEDLE JAMMED IN THE BREAST UPON OBTAINING SAMPLE). ADDITIONAL LIDOCAINE WAS ADMINISTERED AND THE NEEDLE WAS CAREFULLY REMOVED. ANOTHER BIOPSY IN THE SAME AREA OF THE RIGHT BREAST WAS PERFORMED SUCCESSFULLY WITH AN ALTERNATIVE MANUAL DEVICE (BARD MAXCORE). THE PATIENT REPORTED RIGHT BREAST DISCOMFORT AND THE PATIENT'S FAMILY EXPRESSED CONCERN THAT, BECAUSE OF THE MALFUNCTION, THE PATIENT HAD TO LAY ON HER BACK LONGER THAN ANTICIPATED WITHOUT HER BACK BRACE ON. AFTER THE BIOPSY WAS COMPLETED, PRESSURE WITH ICE PACKS WAS APPLIED TO THE BREAST FOR 15 MINUTES AND PATIENT HAD NO FURTHER COMPLICATIONS. THE NEXT DAY THE PATIENT WAS CONTACTED FOR FOLLOW-UP. THE PATIENT REPORTED THAT HER BREAST WAS PAINFUL, HOWEVER THERE WAS VERY LITTLE BRUISING NOTED. SHE WAS INSTRUCTED TO CONTINUE TO USE ICE PACKS AND TAKE PAIN PILLS FOR RELIEF AS NEEDED. THE NEEDLE WILL BE SUBMITTED TO THE BARD REPRESENTATIVE WITH A REQUEST TO INVESTIGATE AND SEND A REPORT OF THEIR FINDINGS TO THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINESSE ULTRA ULTRASOUND BIOPSY PROBE KNW BARD * 80002752

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR