BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTITIAL PLASTIC NEEDLES

    MDR report key: 3443587 · Received September 19, 2013

    Report

    Report Number
    9612638-2013-00011
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    August 5, 2013
    Report Date
    September 19, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K120341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE REMAINS UNDER INVESTIGATION. THE AFFECTED PART WAS ACCIDENTALLY DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED TO VARIAN MEDICAL SYSTEMS FOR ROOT CAUSE ANALYSIS. A F/U REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE ATTEMPTING TO IMPLANT THE PLASTIC NEEDLE (PART AND LOT NUMBERS PENDING) THROUGH A STEERING HOLE IN ONE OF THEIR HOMEMADE APPLICATORS. THE TIP OF THE NEEDLE BROKE OFF DURING THE IMPLANTATION THROUGH THE STEERING HOLE AND INTO THE PT. THE CUSTOMER STATED THAT THEY WERE ABLE TO IDENTIFY THE TIP OF THE NEEDLE WHEN THEY REMOVED THE APPLICATOR THE NEXT DAY AND IT WAS POSSIBLE TO REMOVE IT FROM THE PT AFTER ENDING THE BRACHYTHERAPY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473669 INTERSTITIAL PLASTIC NEEDLES PLASTIC NEEDLE W/MANDRIN 2.0 DIAMETER JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R