BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI (TJ) NEEDLE BM 8G X 6 ASP MAC

    MDR report key: 2284299 · Received October 10, 2011

    Report

    Report Number
    1625685-2011-00021
    Event Type
    Malfunction
    Date Received
    October 10, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    CAREFUSION
    Product Code
    KNW
    PMA / PMN Number
    K003370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR WAS PREVIOUSLY SUBMITTED ON (B)(4) 2011 AND RECEIVED BY THE FDA WITHIN THE REQUIRED 30 DAY REPORTING TIME FRAME BEARING THE REGISTRATION NUMBER OF (B)(4) IN ERROR DUE TO A REPORTING SOFTWARE DISCREPANCY (REPORT #1423537-2011-00045). CAREFUSION HAS DISCUSSED WITH AND BEEN ADVISED BY (B)(6) ON (B)(4) 2011, TO RESUBMIT THE MDR BEARING CAREFUSION'S REGISTRATION NUMBER AND TO INCLUDE THIS VERBIAGE WITHIN THE REPORT, AS WELL AS WITHIN CAREFUSION'S COMPLAINT MANAGEMENT SOFTWARE. EVALUATION SUMMARY: A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPHY PROVIDED BY THE CUSTOMER DID NOT IDENTIFY ANY ISSUES NOR IDENTIFIED ANY MALFUNCTION. 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 REVIEW OF APPLICABLE MANUFACTURING PROCEDURES DID NOT IDENTIFY ANY ISSUES WITH THE CURRENT MANUFACTURING PROCESS 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, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS FAILURE MODE. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS COMPLAINT IN AN EFFORT HEIGHTEN AWARENESS REGARDING THIS FAILURE MODE AND MINIMIZE ANY IMPACT FROM THE MANUFACTURING PROCESSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE CAREFUSION INTERNATIONAL AFFILIATE THAT THE INNER NEEDLE WAS STUCK IN THE OUTER ONE AFTER THE INTENDED PUSHING OUT OF BONE MARROW-CYLINDER. THE INNER NEEDLE BROKE WHILE ROTATING IT IN THE OUTER NEEDLE. THE WHOLE NEEDLE WAS THEN WITHOUT ANY PROBLEM REMOVED FROM THE PATIENT. NO METALLIC DETAIL WAS LEFT IN THE HIP. THE REPORTED CONDITION IS THAT THE TISSUE SAMPLES STAY ON THE HEAD OF THE NEEDLE PROBE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI (TJ) NEEDLE BM 8G X 6 ASP MAC ASPIRATION NEEDLE KNW CAREFUSION TJM6008 L9S155

    Patients

    Seq Age Sex Outcome Treatment
    1