BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASPIRATION TRAY

    MDR report key: 18941027 · Received March 20, 2024

    Report

    Report Number
    18941027
    Event Type
    Other
    Date Received
    March 20, 2024
    Date of Event
    February 21, 2024
    Report Date
    February 29, 2024
    Manufacturer
    CUSTOM HEALTHCARE SYSTEMS, INC.
    Product Code
    OJT
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USING THE CORING NEEDLE, AFTER OBTAINING ACCESS, NEEDLE WAS IN PLACE. AFTER ATTEMPTING TO REMOVE CENTER OF JAMSHIDI, THE CAP/TOP CAME OFF LEAVING THE NEEDLE INSERTED INTO THE PATIENT¿S ILIAC CREST. NEW BONE MARROW KITS BEING EVALUATED DUE TO MULTIPLE BROKEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048286 ASPIRATION TRAY OJT CUSTOM HEALTHCARE SYSTEMS, INC. 66243

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male