BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IODINE125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ

    MDR report key: 12906441 · Received December 1, 2021

    Report

    Report Number
    1018233-2021-07630
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 4, 2021
    Report Date
    December 5, 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: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. HOWEVER, DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE STANDARD CARTRIDGE RAW MATERIAL AND THE SEEDS. THESE LOTS MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED ISSUE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: THE INFORMATIONS FOR USE WAS REVIEWED FOR QUICKLINK DELIVERY SYSTEM. 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 RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807277 IODINE125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ BRACHYTHERAPY LINKS & CARTRIDGES KXK BARD BRACHYTHERAPY, INC. -1424526 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown