BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMAMED PLASTIC NEEDLE WITH MANDRIN

    MDR report key: 1588788 · Received January 19, 2010

    Report

    Report Number
    9612638-2010-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    January 23, 2008
    Report Date
    January 19, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    JAQ
    PMA / PMN Number
    K983436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS CONDUCTED ON STOCK AND THE FIELD FAILURE WAS NOT REPRODUCIBLE UNDER NORMAL USE OR ROUGH HANDLING CONDITIONS. CUSTOMER TECHNICAL BULLETIN WAS SENT TO USERS AND PRODUCT IMPROVEMENTS FOR THE MFG OF THE NEEDLE TIP HAVE BEEN UNDERTAKEN. DETAILS ON THE CORRECTIVE ACTIONS ARE REPORTED TO THE FDA RECALL COORDINATOR.

    Description of Event or Problem · 1

    A PLASTIC NEEDLE 200MM TIP CRACKED DURING A BRACHYTHERAPY IMPLANT. THE TIP CRACK BECAME EVIDENT DURING CT PRIOR TO THE SECOND TREATMENT WHEN THE USER COULD NOT SEE THE PARTICULAR NEEDLE ON THE SCAN. THE NEEDLE WAS NOT USED FOR THE SECOND TREATMENT AND THE PHYSICIST ADOPTED THE PLAN TO COMPENSATE. WHEN THIS NEEDLE WAS REMOVED THERE WAS BLOOD INSIDE AND A TINY CRACK AT THE TIP. THERE WAS A 3 HOUR GAP BETWEEN THE FIRST TREATMENT AND THE SECOND TREATMENT. CT SCAN FROM THE FIRST TREATMENT SHOWS THERE WAS NO BLOOD IN THE NEEDLE. THE NEEDLE WAS OUTSIDE SHELF LIFE. THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other