BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® BRACHYSOURCE® I-125 IMPLANT SEED

    MDR report key: 7047986 · Received November 21, 2017

    Report

    Report Number
    1018233-2017-06024
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Report Date
    February 15, 2018
    Manufacturer
    BARD BRACHYTHERAPY, INC. -1424526
    Product Code
    KXK
    PMA / PMN Number
    K093663
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "WARNINGS AND PRECAUTIONS WARNING: BRACHYSOURCE® SEED IMPLANTS CONTAIN RADIOACTIVE MATERIALS. BRACHYSOURCE® SEED IMPLANTS, LIKE ALL RADIOACTIVE MATERIALS, MUST BE HANDLED WITH CARE. APPROPRIATE SAFETY MEASURES SHOULD BE USED TO MINIMIZE EXPOSURE TO CLINICAL PERSONNEL. PERSONNEL MONITORING IS REQUIRED. TYPICALLY A FILM BADGE OR TLD DOSIMETER WORN ON THE BODY AND A RING BADGE(S) IS ADEQUATE. CARE SHOULD BE TAKEN TO MINIMIZE RADIATION EXPOSURE TO PATIENTS AND OTHER INDIVIDUALS CONSISTENT WITH PROPER THERAPEUTIC MANAGEMENT. DURING THE IMPLANTATION PROCEDURE, ALL PRACTICAL STEPS SHOULD BE EMPLOYED TO MAINTAIN RADIOACTIVE EXPOSURE AS LOW AS REASONABLY ACHIEVABLE. IN CIRCUMSTANCES SUCH AS SURGERY WHEN PROTECTIVE BARRIERS ARE NOT PRACTICAL, OPERATORS MUST RELY UPON PROPER USE OF APPLICATORS, DISTANCE AND SPEED TO MINIMIZE RADIATION EXPOSURE.7,8,9,10 INITIATE RADIATION SURVEYS ON ALL COMPONENTS UPON COMPLETION OF THE SEED IMPLANT. WARNING: NEVER IMPLANT VISIBLY DAMAGED BRACHYSOURCE® SEED IMPLANTS. BRACHYSOURCE® SEED IMPLANTS 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 ENVIRONMENT OR TISSUES SURROUNDING AN IMPLANTED BRACHYTHERAPY SOURCE. BRACHYSOURCE® SEED IMPLANTS THAT HAVE BEEN VISIBLY DAMAGED IN ANY WAY SHOULD BE SEALED IN A CONTAINER AND THE AREA MONITORED FOR POTENTIAL I-125 CONTAMINATION. CAUTION: BIOHAZARD AFTER USE, THE BRACHYSOURCE® SEED IMPLANTS AND ACCESSORIES ARE POTENTIAL BIOHAZARDS. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTABLE MEDICAL PRACTICE AND WITH APPLICABLE LAWS AND REGULATIONS. CAUTION: ACCIDENTAL DAMAGE: BRACHYSOURCE® SEED IMPLANTS ARE SUPPLIED WITH THE RADIOACTIVE I-125 HERMETICALLY SEALED INSIDE A TITANIUM CAPSULE. BRACHYSOURCE® SEED IMPLANTS ARE LEAK CHECKED PRIOR TO SHIPMENT PER ISO 9978, RADIATION PROTECTION ¿ SEALED RADIOACTIVE SOURCES ¿ LEAKAGE TEST METHODS. BRACHYSOURCE® SEED IMPLANTS HAVE HIGH STRUCTURAL INTEGRITY, THOUGH ROUGH HANDLING OR ACCIDENTS MAY CRUSH OR RUPTURE THE BRACHYSOURCE® SEED IMPLANTS. IN THE EVENT OF SUCH DAMAGE, THE AREA CONTAINING THE DAMAGED BRACHYSOURCE® SEED IMPLANTS SHOULD BE CLOSED OFF AND PERSONNEL MOVEMENT SHOULD BE CONTROLLED UNTIL THE PERSONNEL AND AFFECTED AREA CAN BE MONITORED FOR EVIDENCE OF I-125 CONTAMINATION. SUCH MONITORING SHOULD BE PERFORMED IN ACCORDANCE WITH STANDARD PRACTICE. IF NECESSARY, THE AFFECTED AREA AND/OR PERSONNEL SHOULD BE DECONTAMINATED PER STANDARD PRACTICE UNDER THE SUPERVISION OF A QUALIFIED HEALTH PHYSICIST. CAUTION: RADIATION PROTECTION: BRACHYSOURCE® SEED IMPLANTS, LOOSE 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 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. CAUTION: RESTRICTIONS ON USE: BRACHYSOURCE® SEED IMPLANTS AND ACCESSORIES SHOULD BE USED ONLY BY PHYSICIANS WHO ARE QUALIFIED BY TRAINING AND EXPERIENCE IN THE SAFE USE AND HANDLING OF RADIONUCLIDE BRACHYTHERAPY SOURCES AND WHOSE EXPERIENCE AND TRAINING HAS BEEN APPROVED BY THE APPROPRIATE GOVERNMENT AUTHORITIES AUTHORIZED TO LICENSE THE USE OF RADIOACTIVE MATERIALS. BRACHYSOURCE® SEED IMPLANTS SHOULD BE USED IN THOSE FACILITIES THAT HAVE BEEN APPROVED BY THE APPROPRIATE GOVERNMENT AUTHORITIES AUTHORIZED TO LICENSE THE USE OF RADIOACTIVE MATERIALS." (B)(4) THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LID ON THE SEED VIAL WAS NOT SECURED. THE SEEDS WERE KEPT FOR IMPLANTATION AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LID ON THE SEED VIAL WAS NOT SECURED. THE SEEDS WERE KEPT FOR IMPLANTATION AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829108 BARD® BRACHYSOURCE® I-125 IMPLANT SEED I-125 SEEDS LOOSE IN VIAL KXK BARD BRACHYTHERAPY, INC. -1424526 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1