BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ

    MDR report key: 13092378 · Received December 28, 2021

    Report

    Report Number
    1018233-2021-08459
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 2, 2021
    Report Date
    January 10, 2022
    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 DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE CARTRIDGE RAW MATERIAL 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 CARTRDIGE WITH NO ISSUES NOTED. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED ISSUE. BASED UPON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 PROVIDED BY BD REPRESENTS ALL OF 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 RECORD 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. IT WAS FURTHER REPORTED THAT THE CARTRIDGES FLOATED AND EMPTIED WHEN THE LOAD DISPENSE BUTTON WAS PRESSED. 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. IT WAS FURTHER REPORTED THAT THE CARTRIDGES FLOATED AND EMPTIED WHEN THE LOAD DISPENSE BUTTON WAS PRESSED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994540 I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ BRACHYTHERAPY LINKS & CARTRIDGES KXK BARD BRACHYTHERAPY, INC. -1424526 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male