BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOSMART PROGUIDE NEEDLE

    MDR report key: 1003379 · Received February 5, 2008

    Report

    Report Number
    1121753-2008-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    December 1, 2007
    Report Date
    February 4, 2008
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    PMA / PMN Number
    K060349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SOMETIME DURING A HDR BRACHYTHERAPY INTERSTITIAL PROSTATE TREATMENT, THE TIP OF A SHARP PROGUIDE NEEDLE (ABOUT 2MM) BROKE OFF. AT THE TIME OF USE, THE FACILITY DID NOT NOTICE ANY PROBLEMS WITH THE NEEDLES OR OBTURATORS USED AT THE TIME OF INSERTION. THE 2MM PIECE OF THE PROGUIDE NEEDLE WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOSMART PROGUIDE NEEDLE JAQ, HDR REMOTE AFTERLOADING ACCESSORY JAQ NUCLETRON B.V. 189616 PR060000059

    Patients

    Seq Age Sex Outcome Treatment
    1