BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3733771 · Received April 8, 2014

    Report

    Report Number
    1625685-2014-00114
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 11, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FCG
    PMA / PMN Number
    K913306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS: A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPHS PROVIDED WAS ABLE TO CONFIRM THE REPORTED CONDITION. EXAMINATION OF THE PHOTOGRAPHS DID NOT IDENTIFY ANY MANUFACTURING DEFECT OR MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE BREAK. ANY POTENTIAL CONTRIBUTOR COULD NOT BE EVALUATED FURTHER DUE TO A LACK OF INVESTIGATION EVIDENCE. A REVIEW OF COMPLAINT DATA CONFIRMED THERE IS NO ADVERSE TREND RELATED TO THIS OR ANY SIMILAR FAILURE MODE. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. LIKEWISE, A REVIEW OF ALL MANUFACTURING METHODS AND PERSONNEL INVOLVED IN THE ASSEMBLY OF THE DEVICE DETERMINED THERE WAS NO CONTRIBUTION FROM EITHER TO THE REPORTED ISSUE. THE SPECIFIC LOT NUMBER INVOLVED IS UNKNOWN; HOWEVER, IT WAS INDICATED THAT IT COULD BE EITHER 0000525096 OR 0000572631. NO ISSUES WERE FOUND DURING REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THESE LOTS THAT COULD RESULT IN THE REPORTED CONDITION. THIS INCLUDES REVIEW OF ALL RAW MATERIAL AND COMPONENTS USED DURING THE MANUFACTURE OF THE LOTS. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED CONDITION AS THE PHYSICAL SAMPLE WAS NOT AVAILABLE FOR ANALYSIS. IT IS IMPORTANT TO NOTE THAT THE DIRECTIONS FOR USE (DFU) INCLUDED WITH THE PRODUCT INDICATE: ¿INTENDED USE FOR THE POSTERIOR ILIAC CREST BIOPSY TECHNIQUE.¿ IT WILL BE RECOMMENDED TO THE CUSTOMER THAT THE USER REVIEW THE LABELED INSTRUCTIONS AND PRECAUTIONARY WARNINGS RELATED TO ADEQUATE USE OF THIS DEVICE. FAILURE TO FOLLOW ANY OF THESE PRECAUTIONS AND WARNINGS MAY LEAD TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER SPECIMEN RETENTION WITH THE MARROW ACQUISITION CRADLE, THE HANDLE OF THE DEVICE BROKE OFF THE TJM AND WAS STUCK IN THE BONE OF THE PATIENT. IT WAS IMPOSSIBLE TO REMOVE THE NEEDLE FROM THE BONE, EVEN WITH FLAT NOSE PLIERS. THE NEEDLE WAS DRILLED OUT BY SURGERY. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, PHOTOS OF THE AFFECTED UNIT ARE ATTACHED. ON (B)(4) 2014, THE INTERNATIONAL CONTACT (C. ROSSET) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION AS OBTAINED FROM THE CUSTOMER: THERE WAS NO VISIBLE DEFECT OF THE PRODUCT PRIOR TO PATIENT USE; THEY HAD ALSO ALREADY USED NEEDLES FROM THIS LOT WITHOUT A PROBLEM. THE PHYSICIAN USING THE NEEDLE IS AN EXPERIENCED USER. THE PHYSICIAN STATED THE BONE WAS VERY HARD. THE PATIENT IS YOUNG (BORN IN 1990) AND A SPORTSMAN. THE NEEDLE WAS USED IN THE TIBIA AREA AS THERE WAS SUSPICION OF A TUMOR IN THAT AREA EVEN THOUGH THE PHYSICIAN WAS AWARE THE INTENDED USE DOES NOT COVER THIS BONE. IT WAS POSSIBLE TO RETRIEVE THE CORE SAMPLE FROM THE DAMAGED NEEDLE WITH THE MARROW ACQUISITION CRADLE. THE PATIENT IS CURRENTLY DOING FINE. THE LOT NUMBER IS UNKNOWN; IT COULD BE EITHER 0000525096 OR 0000572631.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211102 JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC KIT, NEEDLE, BIOPSY FCG CAREFUSION TJM4008

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention