BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRATION TRAY

    MDR report key: 21085892 · Received January 6, 2025

    Report

    Report Number
    21085892
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 17, 2024
    Report Date
    December 23, 2024
    Manufacturer
    MANUS MEDICAL, LLC
    Product Code
    OJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING A BONE MARROW BIOPSY AND ASPIRATION, THE BONE MARROW ASPIRATE NEEDLE DEFORMED UPON BEING INSERTED INTO THE PATIENT'S BONE. AS A RESULT OF THE NEEDLE BENDING, THE STYLET BECAME JAMMED WITHIN THE NEEDLE AND COULD NOT BE REMOVED. WITH INCREASED EFFORT, WHICH RISKED NEEDLE DISLODGEMENT, THE STYLET WAS EVENTUALLY REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361265 ASPIRATION TRAY OJT MANUS MEDICAL, LLC 68566

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male