BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC

    MDR report key: 2258419 · Received September 21, 2011

    Report

    Report Number
    1625685-2011-00018
    Event Type
    Injury
    Date Received
    September 21, 2011
    Date of Event
    April 27, 2011
    Report Date
    August 25, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FCG
    PMA / PMN Number
    K913306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER DID NOT IDENTIFY ANY ISSUES NOR IDENTIFIED ANY MALFUNCTION. A 24-MONTH REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURE MODES. A THOROUGH REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A DEVICE HISTORY REVIEW (DHR), RAW MATERIAL HISTORY FILES, AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOT SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE FOR THIS FAILURE MODE WAS IDENTIFIED AS MISUSE WHEN USED FOR AN APPLICATION DIFFERENT FROM THE PRODUCT INTENT. BASED ON THE RESULT OF THE INVESTIGATION AND THE IDENTIFIED ROOT CAUSE, NO CORRECTIVE ACTION IS REQUIRED. IT IS THE RECOMMENDATION OF THIS INVESTIGATION FOR THE USER OF THIS BIOPSY NEEDLE SYSTEM TO DISCONTINUE THE USE OF THE NEEDLE AS AN AIDING DEVICE IN ANY OTHER PROCEDURE OTHER THAN THE LABELED INTENDED USE OF A POSTERIOR ILIAC CREST BIOPSY TECHNIQUE IN AN EFFORT TO PRECLUDE THE POTENTIAL OCCURRENCE OF THE REPORTED CONDITION OF FIRST DEGREE BURN. IT IS ALSO RECOMMENDED TO FOLLOW PRECAUTIONS INDICATED IN THE PRODUCT DIRECTIONS FOR USE REGARDING USING THIS PRODUCT ONLY ONCE SINCE RE-USE MAY RESULT IN A NON-FUNCTIONAL PRODUCT OR CONTRIBUTE TO A CROSS CONTAMINATION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO CAREFUSION: AT FIRST, THE PRODUCT TJM4008 WAS USED IN COMBINATION WITH THE COAXIAL NEEDLE TO SUCCESSFULLY ACQUIRE A MARROW SAMPLE FROM THE PATIENT. THEN, A TYCO RFA (RADIO FREQUENCY ABLATION) ELECTRODE WAS INSERTED THROUGH THE SAME COAXIAL NEEDLE TO PERFORM A FURTHER PROCEDURE. AFTER 3 MINUTES, IT WAS NOTICED THAT THE COAXIAL NEEDLE WAS VERY HOT AND CAUSED THIRD-DEGREE-BURN ON THE PATIENT. AFTER THE REMOVAL OF THE RFA ELECTRODE AND THE COAXIAL NEEDLE IT APPEARED THAT THE INSULATION OF THE RFA ELECTRODE WAS DAMAGED AND GOT IN DIRECT CONTACT WITH THE COAXIAL NEEDLE. IT APPEARED THAT THE SPIKES/CROWN OF THE DISTAL TIP OF THE COAXIAL NEEDLE BENT INWARDS AND REDUCED THE INNER DIAMETER OF THE COAXIAL NEEDLE WHICH AGAIN LEAD TO THE DAMAGE OF THE RFA ELECTRODE ISOLATION. THE DAMAGED INSULATION CAUSED DIRECT CONTACT OF THE RFA ELECTRODE AND THE COAXIAL NEEDLE. HENCE, ELECTRICITY WAS ABLE TO FLOW AND HEATED UP THE COAXIAL NEEDLE IN ITS ENTIRE LENGTH. CONSEQUENCES FOR THE PATIENT: AT FIRST, A BURN HEALING PROBLEM. THEN, A SURGICAL PROCEDURE AFTER 5 DAYS. THE WOUND THEN HEALED AND THE PATIENT WAS FINE. THE SAMPLE WAS DISCARDED; HOWEVER, THERE WERE PHOTOGRAPHS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC JAMSHIDI CROWN BM BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE FCG CAREFUSION TJM4008 L1A325

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention