BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAMSHIDI BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH

    MDR report key: 2071847 · Received April 21, 2011

    Report

    Report Number
    MW5020383
    Event Type
    Injury
    Date Received
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CARE FUSION COMPANY
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INDIVIDUALLY SUPPLIED JAMSHIDI BONE MARROW BIOPSY/ASPIRATION NEEDLE, WITH LUER-LOCK ADAPTER - 11GA X 10CM. OVER THE PAST TWO MONTHS, THERE HAVE BEEN THREE SEPARATE CASES WHERE THE BONE CORE SPECIMENS DID NOT REMAIN IN THE NEEDLE CANNULA, BUT WERE LEFT IN THE SOFT TISSUE OF THE PATIENT AT THE CANNULA EXIT SITE. OTHER RECENT PROVIDER COMPLAINTS ABOUT THE NEEDLES DURING BIOPSY PROCEDURE INCLUDE: THE NEEDLE INTRODUCER DOES NOT FIT SMOOTHLY IN THE CANNULA CREATING A SENSATION OF FIDRAGFL. THE SHEPHERD HOOK PROBE USED TO REMOVE THE CORE SAMPLE FROM THE CANNULA DOES NOT CONSISTENTLY FIT SMOOTHLY IN THE CANNULA MAKING IT VERY DIFFICULT TO REMOVE THE BIOPSY SAMPLE. THIS IS A POTENTIAL HAZARD FOR THE OPERATOR AS THE HOOK CAN SLIP FROM THE INSERTION END OF THE CANNULA. THE JAMSHIDI NEEDLES ON OCCASION HAVE BENT AND NOT FROM OPERATOR TECHNIQUE. PROD. REF. # (B)(4) LOT# D101110145 EXP DATE: 11/2015. THE CARE FUSION COMPANY THAT SUPPLIES THE JAMSHIDI BONE MARROW/ASPIRATION NEEDLE HAS BEEN CONTACTED, AWAITING A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH BIOPSY NEEDLE KNW CARE FUSION COMPANY D101110145

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability