BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPSYSTEM SET JAMSHIDI NEEDLE

    MDR report key: 19104336 · Received April 15, 2024

    Report

    Report Number
    19104336
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 25, 2024
    Manufacturer
    H.S. HOSPITAL SERVICE S.P.A
    Product Code
    KNW
    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

    DURING A BONE MARROW BIOPSY, THE NEEDLE WAS SUCCESSFUL PLACED, AND A CORE SAMPLE OBTAINED. HOWEVER, THE CUTTER WOULD NOT GO ALL THE WAY INTO THE NEEDLE TO RETRIEVE THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509538 TRAPSYSTEM SET JAMSHIDI NEEDLE INSTRUMENT, BIOPSY KNW H.S. HOSPITAL SERVICE S.P.A 52034

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female