BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRAPSYSTEM SET

    MDR report key: 20733769 · Received November 20, 2024

    Report

    Report Number
    20733769
    Event Type
    Death
    Date Received
    November 20, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 13, 2024
    Manufacturer
    H.S. HOSPITAL SERVICE SPA
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A BONE MARROW BIOPSY IN THE PRONE POSITION. DURING SAMPLING, THE PROVIDER ATTACHED A SAMPLE TUBE TO THE LUER LOCK MECHANISM ON THE CORE BIOPSY NEEDLE HANDLE, WHICH BROKE OFF. THE PROVIDER HAD TO REMOVE THE CORE BIOPSY NEEDLE WHICH HAD BEEN PLACED IN THE RIGHT ILIAC CREST, OBTAIN ANOTHER CORE NEEDLE, AND REINSERT AT THE SAME SITE TO FINISH THE SAMPLING. THE PATIENT EXPERIENCED AFTER RETURNING TO THE FLOOR UNIT A SUDDEN CARDIAC ARREST AND EXPIRED. ON AUTOPSY, THE PATIENT HAD A LARGE RETROPERITONEAL HEMATOMA NEAR THE BIOPSY SITE. IT IS UNCLEAR IF THERE IS A DIRECT NEXUS BETWEEN HAVING TO REPLACE THE NEEDLE DURING THE PROCEDURE AND THE HEMATOMA. HOWEVER, GIVEN THE TIMING AND LOCATION THIS SEEMS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008803 TRAPSYSTEM SET INSTRUMENT, BIOPSY KNW H.S. HOSPITAL SERVICE SPA TRAPSYSTEM SET

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death