BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ

    MDR report key: 20662018 · Received November 12, 2024

    Report

    Report Number
    1018233-2024-07127
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 14, 2024
    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: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, A PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE CARTRIDGE, SOURCECAP, AND SEEDS. NO ISSUES WERE NOTED. INVESTIGATION SUMMARY: NO SAMPLE WAS RETURNED FOR EVALUATION. HOWEVER A PHOTO WAS PROVIDED BY THE CUSTOMER. THE PHOTO SHOWS ONE SEED/SOURCECAP ASSEMBLY PROTRUDING FROM THE EXIT HOLE OF THE MICK MAGAZINE. PER THE FIELD ASSURANCE TEAM, THIS PHOTO WAS TAKEN IMMEDIATELY UPON REMOVAL OF THE CARTRIDGE FROM THE SHIELDED CONTAINER, HOWEVER THE MAGAZINE HAS BEEN REMOVED FROM THE SEALED POUCH THAT IT WAS SHIPPED IN. THE MAGAZINE HEAD APPEARS TO BE FULLY TIGHTENED TO THE MAGAZINE BASE. NO EXPOSED THREADS CAN BE SEEN IN THE PHOTO, INDICATING THAT THE HEAD FULLY TIGHTENED, OR NEARLY FULLY TIGHTENED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED ISSUE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: HE INFORMATION FOR USE (IFU) FOR THE CUSTOMER SALES ORDERS IS PK0319941 12/2018. THERE IS A WARNING STATEMENT "NEVER IMPLANT VISIBLY DAMAGED BRACHYSOURCE® SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS. BRACHYSOURCE® SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS SHOULD NEVER BE HANDLED ROUGHLY OR FORCED INTO ANY IMPLANT DEVICE, MAGAZINE OR NEEDLE. SUCH FORCE MAY DAMAGE THE WALL OF THE BRACHYTHERAPY SOURCE, POTENTIALLY CAUSING RELEASE OF I-125 INTO THE TISSUES SURROUNDING AN IMPLANTED BRACHYTHERAPY SOURCE OR INTO THE ENVIRONMENT." ADDITIONALLY, THERE IS A WARNING STATEMENT REGARDING MICK MAGAZINES "DO NOT HANDLE MICK® CARTRIDGES BY THE SPRING LOADED PLUNGER." "DO NOT OVERTIGHTEN THE ROUND MICK® CARTRIDGES HEAD." "DO NOT USE FORCE ON SEEDS OR CARTRIDGES." THERE IS A CAUTION STATEMENT: "CAUTION: RADIATION PROTECTION. CAUTION: RADIATION PROTECTION BRACHYSOURCE® SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS PRELOADED IN NEEDLES OR MICK® CARTRIDGES ARE SHIPPED STERILE IN A SHIELDED SHIPPING CONTAINER DESIGNED TO ATTENUATE >99.9% OF THE PHOTONS FROM I-125. FOLLOWING REMOVAL FROM THE SHIPPING CONTAINER, STORE BRACHYSOURCE® SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS BEHIND APPROPRIATE SHIELDING UNTIL THEIR USE. THE HALF-VALUE THICKNESS OF LEAD FOR I-125 IS 0.025MM. THUS, A 0.25MM LEAD SHEET WILL PROVIDE >99.9 % REDUCTION IN EXPOSURE BRACHYSOURCE® SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS PRELOADED IN NEEDLES OR MICK® CARTRIDGES ARE SHIPPED STERILE IN A SHIELDED SHIPPING CONTAINER DESIGNED TO ATTENUATE >99.9% OF THE PHOTONS FROM I-125. FOLLOWING REMOVAL FROM THE SHIPPING CONTAINER, STORE BRACHYSOURCE® SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS BEHIND APPROPRIATE SHIELDING UNTIL THEIR USE. THE HALF-VALUE THICKNESS OF LEAD FOR I-125 IS 0.025MM. THUS, A 0.25MM LEAD SHEET WILL PROVIDE >99.9 % REDUCTION IN EXPOSURE." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE BOTTOM SOURCE IS ALLEGEDLY STICKING OUT OF THE CARTRIDGE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE BOTTOM SOURCE IS ALLEGEDLY STICKING OUT OF THE CARTRIDGE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058438 I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ BRACHYTHERAPY SEEDS KXK BARD BRACHYTHERAPY, INC. -1424526 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown