BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMAMED PLASTIC NEEDLE WITH MANDRIN

    MDR report key: 1061769 · Received June 13, 2008

    Report

    Report Number
    9612638-2008-00003
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 13, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS CONDUCTED ON STOCK AND THE REPORTED FIELD FAILURE WAS NOT REPRODUCED UNDER NORMAL USE CONDITIONS OR ROUGH HANDLING CONDITIONS. THIS REPORT IS BASED ON INFORMATION RECEIVED FROM A THIRD PARTY OR DEVELOPED BY VARIAN MEDICAL SYSTEMS. WHILE THE REPORTED EVENT IS BEING INVESTIGATED, SOME OF THE FACTS ARE AS YET UNVERIFIED.

    Description of Event or Problem · 1

    DURING A BRACHYTHERAPY TREATMENT, ONE IMPLANTED NEEDLE LOST THE TIP AND REMAINED IN THE PATIENT. CUSTOMER REPORTED THE PATIENT CODED AND AFTER REVIVAL IT WAS DETERMINED THAT THE TIP OF THE NEEDLE HAD BEEN COMPROMISED IN THE PATIENT. THE PROBLEM WAS NOTED WHEN THE DUMMY WIRE WAS REMOVED AFTER SCANNING, AND THE CATHETER IMMEDIATELY QUARANTINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMAMED PLASTIC NEEDLE WITH MANDRIN BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS GM11007570 C38 - 47

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other