BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRATION TRAY

    MDR report key: 20682929 · Received November 14, 2024

    Report

    Report Number
    20682929
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 10, 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

    I WAS COMPLETING A BONE MARROW BIOPSY PROCEDURE AND ASPIRATING THE BONE MARROW ASPIRATE. DURING THE BONE MARROW ASPIRATION, THE TROCHAR LUER LOCK HUB SNAPPED/SPLIT IN HALF DURING ASPIRATION. I WAS UNABLE TO COMPLETE THE ASPIRATION DUE TO AIR FILLING THE SYRINGE. I HAD TO REMOVE MY NEEDLE OBTAIN A NEW TROCHAR NEEDLE AND REINSERT IT TO COMPLETE THE PROCEDURE. THIS CAUSED INCREASED PATIENT DISCOMFORT AND BLEEDING DUE TO SECOND INSERTION OF THE NEW TROCHAR NEEDLE AT THE BIOPSY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217146 ASPIRATION TRAY OJT MANUS MEDICAL, LLC 67147

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male