BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAMSHIDI BONE MARROW PROCEDURE TRAY

    MDR report key: 35774 · Received July 3, 1996

    Report

    Report Number
    35774
    Event Type
    Injury
    Date Received
    July 3, 1996
    Date of Event
    January 31, 1996
    Report Date
    March 15, 1996
    Manufacturer
    BAXTER HEALTH CARE CORP.
    Product Code
    LWE
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A BONE MARROW BIOPSY PROCEDURE THE CATHETER BROKE OFF AT THE HANDLE. PT WENT TO THE OPERATING ROOM FOR REMOVAL OF FOREIGN BODY FROM THE ILIAC CREST. THE MD STATES THAT WHEN HE TURNED THE HANDLE DURING THE BIOPSY, THE HANDLE BECAME STRIPPED FROM THE CATHETER. THE HANDLE WOULD TURN BUT NOT THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI BONE MARROW PROCEDURE TRAY BONE MARROW ASPIRATION NEEDLE/KIT & JAMSHIDI NEEDLE LWE BAXTER HEALTH CARE CORP. EJT4511 *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention