BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAMSHIDI (TJ) NEEDLE BONE MARROW 8GX4

    MDR report key: 2122869 · Received June 14, 2011

    Report

    Report Number
    1625685-2011-00013
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS MADE AVAILABLE, SECTION D HAS BEEN UPDATED ACCORDINGLY. EVALUATION SUMMARY: A COMPLAINT SAMPLE WAS PROVIDED AFTER THE ORIGINAL INVESTIGATION WAS COMPLETED. EVALUATION OF THE COMPLAINT SAMPLE CONFIRMED THE NEEDLE WAS FRACTURED. INSPECTION OF THE FRACTURED COMPONENT SUGGESTED THE NEEDLE WAS BENT DUE TO EXCESSIVE FORCE; HOWEVER, THE REPORTED CONDITION COULD NOT BE DEFINITIVELY CONFIRMED BY THE COMPLAINT INVESTIGATION. A REVIEW OF COMPLAINT DATA IDENTIFIED A PREVIOUS COMPLAINT OF SIMILAR NATURE. A REVIEW OF THE PREVIOUS INVESTIGATION DID NOT IDENTIFY ANY ADDITIONAL EVIDENCE TO AID IN THE IDENTIFICATION OF THE ROOT CAUSE FOR THE CURRENT COMPLAINT. A THOROUGH REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW (DHR), RAW MATERIAL HISTORY FILES, AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOTS SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED CONDITION. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS FAILURE MODE IN AN EFFORT TO HEIGHTEN AWARENESS OF THIS COMPLAINT AND MINIMIZE ANY IMPACT FROM THE MANUFACTURING PROCESSES. APPROPRIATE FEEDBACK WILL BE RECOMMENDED TO CAREFUSION'S ACCOUNT REPRESENTATIVE. PROFESSIONAL FEEDBACK MAY INCLUDE, BUT IS NOT LIMITED TO, BEST-PRACTICE TECHNIQUES, LABELED INSTRUCTIONS AND PRECAUTIONARY WARNINGS RELATED TO EXCEEDING THE TORSIONAL STRESS LIMITS OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS PROVIDED FOR EVALUATION, THEREFORE; THE QUALITY OF THE BONE MARROW NEEDLE ASSEMBLY CANNOT BE EVALUATED. THEREFORE; WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE FAILURE REPORTED. 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 LOTS SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS FAILURE MODE IN AN EFFORT TO HEIGHTEN AWARENESS OF THIS COMPLAINT AND MINIMIZE ANY IMPACT FROM THE MANUFACTURING PROCESSES.

    Description of Event or Problem · 1

    DURING THE SAMPLING OF BONE MARROW FROM THE ILIAC CREST A PIECE OF 2.5CM OF THE NEEDLE BROKE OFF INTO THE PATIENT. THE PATIENT REQUIRED A SURGICAL PROCEDURE TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI (TJ) NEEDLE BONE MARROW 8GX4 JAMSHIDI (TJ) NEEDLE BONE MARROW 8GX4 FCG CAREFUSION TJC4008 LOJ221

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention