BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IODINE 125 SEEDS IN QUICKLINK , STERILE, 11.0 MBQ

    MDR report key: 13060156 · Received December 22, 2021

    Report

    Report Number
    1018233-2021-08315
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 25, 2021
    Report Date
    November 29, 2021
    Manufacturer
    BARD BRACHYTHERAPY, INC. -1424526
    Product Code
    KXK
    PMA / PMN Number
    K093663
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE CARTRIDGE AND SEEDS. THESE LOT MET ALL RELEASE CRITERIA. NO ISSUES WERE NOTED. INVESTIGATION SUMMARY: ONE EMPTY SEED CARTRIDGE WAS RETURNED FOR EVALUATION. UPON INITIAL INSPECTION, THE SEED CARTRIDGES GATES CLOSED PROPERLY. NO SPRING PROTRUSION WAS NOTICED ON THE BACKSIDE OF THE CARTRIDGE. PLUNGER TRAVEL APPEARED FINE. TWENTY SEEDS WERE LOADED INTO THE CARTRIDGE AND INSERTED INTO A QUICKLINK LOADER. ALL 20 SEEDS DISPENSED FROM THE CARTRIDGE WITH NO ISSUES NOTED. THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THERE IS A CAUTION STATEMENT, WHICH STATES "IN THE EVENT THE QUICKLINK¿ LOADER OR CARTRIDGES BECOME INOPERABLE DUE TO DAMAGE OR MALFUNCTION, ANY OR ALL COMPONENTS MAY BE REMOVED FROM THE CARTRIDGES AND IMPLANTED MANUALLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO EJECT THREE SEEDS WHEN TWENTY SEEDS IN THE CARTRIDGE WERE ATTEMPTED TO BE DISCHARGED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965250 IODINE 125 SEEDS IN QUICKLINK , STERILE, 11.0 MBQ BRACHYTHERAPY SEEDS KXK BARD BRACHYTHERAPY, INC. -1424526 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male