BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA

    MDR report key: 8374761 · Received February 27, 2019

    Report

    Report Number
    3011137372-2019-00066
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    February 20, 2019
    Report Date
    February 22, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FCG
    PMA / PMN Number
    K113872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FILE IS NOT AVAILABLE FOR REVIEW IN THE US. RECEIVED (1) 9464-VC-006, ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA, ACCESS AND BIOPSY SET RETURNED FOR INVESTIGATION. THE ORANGE 13 GA BIOPSY NEEDLE WAS ASSEMBLED INTO THE GREEN 11 GA ACCESS NEEDLE. FROM A VISUAL EXAMINATION OF THE SET WITH NAKED EYE, THE ORANGE 13 GA. BIOPSY NEEDLE HAD MOVED BEYOND THE TIP END OF THE 11 GA. GREEN ACCESS NEEDLE AND THE TIP OF THE 13 GA. ORANGE BIOPSY NEEDLE TWISTED OFF INTO THE PATIENT'S BONE. THE PIECE THAT TWISTED OFF WAS RETURNED BUT WAS PHYSICALLY MANGLED. A SECTION OF THE IFU WILL BE REFERENCED AS PART OF THIS INVESTIGATION REPORT. THE IFU STATES, "LOCATE INSERTION SITE WITH NEEDLE SET ON THE PERIOSTEUM. NOTE DEPTH MARKING. SQUEEZE TRIGGER TO PENETRATE CORTEX TO MEDULLARY SPACE. DO NOT APPLY EXCESSIVE FORCED TO DRIVER/NEEDLE SET." ADDITIONAL DOCUMENT REVIEW WAS NOT PERFORMED. THE BATCH/LOT # THAT WAS REPORTED WAS NOT VALID FOR A CERTIFICATE OF COMPLIANCE REVIEW. THE DAMAGED NEEDLE SET HAS BEEN CONFIRMED. HOWEVER, WITH THE LACK OF DETAIL CONCERNING THE CIRCUMSTANCES OF THE INCIDENT A ROOT CAUSE CANNOT BE DEFINITIVELY ESTABLISHED. HOWEVER, GIVEN THE AMOUNT OF PHYSICAL PRESSURE NEEDED TO DO THIS KIND OF METALLIC NEEDLE DAMAGE, AND FROM AN INVESTIGATIVE OBSERVATION, UNINTENTIONAL USER ERROR APPEARS TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    THE COMPLAINT STATES THAT DURING A BIOPSY THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT'S TIBIA. THE TIP WAS REMOVED SURGICALLY BY ORTHOPEDICS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE COMPLAINT STATES THAT DURING A BIOPSY THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT'S TIBIA. THE TIP WAS REMOVED SURGICALLY BY ORTHOPEDICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167733 ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA BIOPSY NEEDLE KIT FCG TELEFLEX MEDICAL 27511634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention