BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I125 SEEDS IN QUICKLINK, STERILE, 11.0 MBQ

    MDR report key: 15182073 · Received August 8, 2022

    Report

    Report Number
    1018233-2022-06119
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 13, 2022
    Report Date
    September 22, 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

    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. HOWEVER; PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. DEVICE PENDING RETURN.

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER. THE LOT MET ALL RELEASE CRITERIA. NO ISSUES WERE NOTED. INVESTIGATION SUMMARY: THE SAMPLE (SHIELD FOAM INSERT (UPPER AND LOWER)) ALONG WITH THE PEWTER SHIELD WAS RETURNED FOR EVALUATION. BLACK LOOSE PARTICLE/FRAGMENT/DUST WAS PRESENT INTO THE UPPER SHIELD FOAM INSERT. HOWEVER THIS PARTICLE WAS INTO THE SHIELD FOAM INSERT, NOT ON OR IN CONTACT WITH THE DEVICE AND DOES NOT AFFECT THE DEVICE PERFORMANCE. THE SHIELD FOAM INSERT IS PART OF THE PACKAGING INSIDE THE PEWTER SHIELD. THE QUICKLINK CARTRIDGES ARE PLACED WITHIN THE LOWER SHIELD FOAM INSERT AND COVERED WITH THE UPPER SHIELD FOAM INSERT INSIDE THE PEWTER SHIELD. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED ISSUES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THERE IS A CAUTION STATEMENT, WHICH STATES "DO NOT USE IF THE PACKAGE IS DAMAGED" AND THAT THE PRODUCT WAS STERILE. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A BRACHYTHERAPY PROCEDURE, THERE WAS SOMETHING LIKE SMALL BLACK DUST ON THE SPONGE PART OF THE SEED STORAGE INSIDE THE SEED PACKAGE. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A BRACHYTHERAPY PROCEDURE, THERE WAS SOMETHING LIKE SMALL BLACK DUST ON THE SPONGE PART OF THE SEED STORAGE INSIDE THE SEED PACKAGE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154663 I125 SEEDS IN QUICKLINK, STERILE, 11.0 MBQ BRACHYTHERAPY SEEDS KXK BARD BRACHYTHERAPY, INC. -1424526 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male