BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY SYSTEM COMPREHENSIVE TRAY

    MDR report key: 10153188 · Received June 15, 2020

    Report

    Report Number
    3011137372-2020-00134
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    June 3, 2020
    Report Date
    June 4, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FCG
    PMA / PMN Number
    K113872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR IS NOT AVAILABLE FOR REVIEW. RECEIVED ONE BONE ACCESS CANNULA FROM A 9458-VC-006, BIOPSY SYSTEM COMPREHENSIVE TRAY. AT VISUAL INSPECTION THE REPORTED DEFECT WAS CONFIRMED: BONE ACCESS CANNULA HAD BEEN BROKEN OFF FROM ITS HUB; THE HUB WAS NOT RETURNED. UNDER MAGNIFICATION THE BREAK APPEARS TO HAVE TWISTED OFF. THERE WERE MULTIPLE BENDS OBSERVED IN THE CANNULA BODY. A SECTION OF THE IFU WILL BE REFERENCED AS PART OF THIS INVESTIGATION REPORT. THE IFU STATES, "4. INSERT BONE ACCESS NEEDLE SET INTO INTENDED LOCATION USING THE CORRECT ANGLE. ATTACH DRIVER TO NEEDLE SET. WHEN CORRECTLY INSERTED, THE NEEDLE SET WILL SECURE INTO CONNECTOR WITH A "CLICK". TIGHTEN STYLET AND HUB OF THE BONE ACCESS NEEDLE SET. FIND LOCATION ON BONE, NOTE DEPTH MARKING AND SQUEEZE TRIGGER TO ACTIVATE DRIVER. DO NOT APPLYEXCESSIVE FORCE TO DRIVER/NEEDLE SET. SQUEEZE TRIGGER UNTIL BONE ACCESS NEEDLE SET HAS REACHED THE DESIRED LOCATION TO BE BIOPSIED. DETACH POWER DRIVER FROM THE BONE ACCESS NEEDLE SET. DETACH POWER DRIVER FROM THE BONE LESION BIOPSY NEEDLE SET. REMOVE STYLET. IF NEEDED, USE THE MANUAL HANDLE FOR MINOR ADJUSTMENTS OF THE BONE ACCESS CANNULA. BONE LESION BIOPSY NEEDLE SET SHOULD ALWAYS BE USED INSIDE THE ACCESS NEEDLE. DO NOT USE THE BONE LESION BIOPSY NEEDLE SET INDEPENDENTLY OF THE ACCESS NEEDLE. PLACE THE BONE LESION BIOPSY NEEDLE INSIDE THE BONE ACCESS CANNULA. FOR BONE LESION, ATTACH POWER DRIVER TO BONE LESION BIOPSY NEEDLE HUB, USE DEPTH MARKERS AS GUIDE. IN ONE CONTINUOUS MOTION, SQUEEZE TRIGGER, AND ADVANCE BONE LESION BIOPSY NEEDLE (UP TO 1.5 CM AS ALLOWED BY THE BONE ACCESS CANNULA); WITH THE TRIGGER STILL ENGAGED, PULL UP ON POWER DRIVER UNTIL BONE LESION BIOPSY NEEDLE IS COMPLETELY REMOVED FROM PATIENT. A REVIEW OF THE CERTIFICATE OF CONFORMANCE FOUND THAT THE NEEDLE SET PASSED ALL THE RELEASE CRITERIA. THE DEVICE WAS RELEASED IN 09/2019 AND IS APPROXIMATELY 1 YEAR OLD. THE COMPLAINT HAS BEEN CONFIRMED. THE PROBABLE CAUSE OF THE DAMAGE IS UNINTENTIONAL USER ERROR - PATIENT CONDITION. NO CORRECTIVE/P REVENTATIVE ACTIONS WILL BE ASSIGNED. THE COMPLAINT HAS BEEN CONFIRMED. CLOSE UP PHOTOS REVEAL THE TWISTED METAL END OF THE LESION BIOPSY NEEDLE. THE BREAKAGE DOES NOT REFLECT ANY CHARACTERISTICS THAT WOULD POINT TO A MANUFACTURING MATERIAL OR PROCESS DEFICIENCY. THE COMPLAINT HAS BEEN CONFIRMED, UNINTENTIONAL USER ERROR MOST LIKELY CAUSED OR CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BONE MARROW BIOPSY WAS ATTEMPTED ON A PATIENT WITH HARD BONE. WHILE THE OPERATOR WAS ADVANCING THE DRIVER INTO HARD BONE THE PATIENT JERKED CAUSING THE DISTAL PORTION OF THE BIOPSY NEEDLE TO BEND AND THE TWISTING OFF AND SEPARATION OF THE HUB FROM BIOPSY NEEDLE. THE HUB WHERE THE DRIVER ATTACHES TO. THE BIOPSY NEEDLE WAS REMOVED WITH HEMOSTATS.

    Additional Manufacturer Narrative · 1

    QN# (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

    IT WAS REPORTED THAT A BONE MARROW BIOPSY WAS ATTEMPTED ON A PATIENT WITH HARD BONE. WHILE THE OPERATOR WAS ADVANCING THE DRIVER INTO HARD BONE THE PATIENT JERKED CAUSING THE DISTAL PORTION OF THE BIOPSY NEEDLE TO BEND AND THE TWISTING OFF AND SEPARATION OF THE HUB FROM BIOPSY NEEDLE. THE HUB WHERE THE DRIVER ATTACHES TO. THE BIOPSY NEEDLE WAS REMOVED WITH HEMOSTATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616743 BIOPSY SYSTEM COMPREHENSIVE TRAY BIOPSY NEEDLE KIT FCG TELEFLEX MEDICAL 34329173

    Patients

    Seq Age Sex Outcome Treatment
    1