BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I125 SEEDS IN QUICKLINK, STERILE, 11.0 MBQ

    MDR report key: 12809609 · Received November 15, 2021

    Report

    Report Number
    1018233-2021-07233
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 16, 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

    H10: UPON ADDITIONAL INFORMATION, FIVE SAMPLES WERE RECEIVED, HOWEVER, THE FAILURE EVENT WAS OCCURRED ONLY ONE SAMPLE AND ALSO IT CANNOT BE DETERMINED WHICH SAMPLE MALFUNCTIONED AMONG THE RETURNED FIVE DEVICES, THEREFORE, ALL THE FIVE DEVICES EVALUATION DETAILS WILL BE CAPTURED IN THE MDR. H10: MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. INVESTIGATION SUMMARY: FIVE (5) EMPTY SEED CARTRIDGES WERE RETURNED FOR EVALUATION AND LABELED AS BIOHAZARDOUS. UPON INITIAL INSPECTION, THE SEED CARTRIDGES GATES CLOSED PROPERLY. NO SPRING PROTRUSION WAS NOTICED ON THE BACKSIDE OF THE CARTRIDGES. PLUNGER TRAVEL APPEARED FINE. TWENTY SEEDS WERE LOADED INTO THE CARTRIDGES AND INSERTED INTO A QUICKLINK LOADER. ALL 20 SEEDS DISPENSED AS EXPECTED ON ALL FIVE (5) CARTRIDGES WITH NO ISSUES NOTED. THE COMPLAINT WAS FOUND UNCONFIRMED FOR REPORTED ISSUE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: THE INFORMATION FOR USE WAS REVIEWED. 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."

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE SEED ALLEGEDLY COULD NOT BE DISCHARGED FROM THE LOADER. IN ADDITION, THE SEED MIGRATED INTO THE LOADER. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE SEED ALLEGEDLY COULD NOT BE DISCHARGED FROM THE LOADER. IN ADDITION, THE SEED MIGRATED INTO THE LOADER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714205 I125 SEEDS IN QUICKLINK, STERILE, 11.0 MBQ BRACHYTHERAPY SEEDS KXK BARD BRACHYTHERAPY, INC. -1424526 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male