BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IODINE 125 SEEDS IN QUICKLINK , STERILE, 11.0 MBQ

    MDR report key: 12861486 · Received November 23, 2021

    Report

    Report Number
    1018233-2021-07484
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 28, 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: MANUFACTURING REVIEW: A LOT HISTORY REVIEW, A DEVICE HISTORY RECORD REVIEW AND COMPLETE MANUFACTURING REVIEW COULD NOT BE CONDUCTED FOR THE INVESTIGATION AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: THE SAMPLE USED BY THE CUSTOMER WAS RETURNED, AND DURING EVALUATION THE SAMPLE OPERATED AS INTENDED WITH NO ISSUES NOTED. EMPTY SEED CARTRIDGES WERE RETURNED FROM THE CUSTOMER 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 CARTRIDGE WITH NO ISSUES NOTED. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED DIFFICULT TO DISCHARGE ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE 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." H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    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 RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE SEEDS ALLEGEDLY COULD NOT BE DISCHARGED FROM THE LOADER. ALL THE SEEDS WERE TAKEN OUT FROM THE CARTRIDGE AND ARRANGED ONE BY ONE ON THE ASSEMBLY BASE AND DISCHARGED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE SEEDS ALLEGEDLY COULD NOT BE DISCHARGED FROM THE LOADER. ALL THE SEEDS WERE TAKEN OUT FROM THE CARTRIDGE AND ARRANGED ONE BY ONE ON THE ASSEMBLY BASE AND DISCHARGED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759289 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