BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMAMED PLASTIC NEEDLE WITH MANDRIN

    MDR report key: 1061779 · Received June 13, 2008

    Report

    Report Number
    9612638-2008-00004
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 13, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    K983436
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS CONDUCTED ON STOCK, INCLUDING THE SAME AS THE REPORTED LOT, AND THE FIELD FAILURE WAS NOT REPRODUCED UNDER NORMAL USE OR ROUGH HANDLING CONDITIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TIP OF AN INTERSTITIAL PLASTIC NEEDLE, 2.0MM DIAMETER, LENGTH 200MM BROKE IN THE PT'S LIVER. THIS WAS NOT RECOGNIZED BEFORE THE TREATMENT, SO THE DUMMY WIRE AS WELL AS THE SOURCE WIRE GOT CONTAMINATED WITH BODY FLUID. THERE IS A CRACK THAT BRIDGES TO THE NEEDLE BODY AND BLOOD IS INSIDE THE NEEDLE TUBE. BY THE CABLE THIS BLOOD WAS PULLED INTO THE SGT AND THE AFTERLOADER. THE TREATMENT WAS COMPLETELY ACCOMPLISHED. NEGATIVE CONSEQUENCES ARE NOT TO BE EXPECTED. THE VERY SMALL PIECE CANNOT BE SOUNDED OUT IN THE LIVER. INFECTION SIGNS DO NOT EXIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMAMED PLASTIC NEEDLE WITH MANDRIN BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS GM11007570 LOT I12-015

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other