BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERASEED PD-103

    MDR report key: 6898168 · Received September 27, 2017

    Report

    Report Number
    1037598-2016-00001
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Manufacturer
    THERAGENICS CORPORATION
    Product Code
    KXK
    UDI-DI
    00813787020846
    PMA / PMN Number
    K040339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE ORDER FORM, IT WAS CONFIRMED THAT THE UNITS OF ACTIVITY ORDERED BY THE CUSTOMER WAS CONVERTED INCORRECTLY DURING THE ORDER ENTRY PROCESS. THERAGENICS TAKES PD-103 ORDERS IN UNIST (U). THE CUSTOMER SUBMITTED THE ORDER IN MILLICURIES (MCI). THE CUSTOMER SERVICE REPRESENTATIVE INCORRECTLY ENTERED THE MCI ACTIVITY AS U. THE ERROR WAS NOT DETECTED DURING THE ORDER ENTRY VERIFICATION PROCESS PRIOR TO SHIPMENT OF THE ORDER NOR DURING THE CUSTOMER'S ORDER CONFIRMATION PROCESS. UPON QUALITY REVIEW OF THE RECEIVED ORDER AT THE USERS FACILITY, THE DISCREPANCY WAS DETECTED, AND THE PLANNED TREATMENT WAS REPLACED AND RESCHEDULED WITH THE CORRECT ACTIVITY ORIGINALLY PLANNED. THERE WAS NO FAILURE OR MALFUNCTION. THE SEED ORDER WAS FILLED WITH A HIGHER THAN REQUESTED ACTIVITY, WHICH WOULD HAVE RESULTED IN A MISADMINISTRATION.

    Description of Event or Problem · 1

    SEED ACTIVITY FOR BRACHYTHERAPY ORDER WAS ENTERED USING THE WRONG UNITS CAUSING A DISCREPANCY BETWEEN ORDERED SEED STRENGTH AND THE SEED STRENGTH THAT WAS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679059 THERASEED PD-103 RADIONUCLIDE BRACHYTHERPY SOURCE KXK THERAGENICS CORPORATION ON72X 1642F 00813787020846

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention