BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM HEALTHCARE SYSTEMS

    MDR report key: 18217209 · Received November 28, 2023

    Report

    Report Number
    18217209
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 13, 2023
    Report Date
    November 16, 2023
    Manufacturer
    CUSTOM HEALTHCARE SYSTEMS, INC.
    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

    THE BONE MARROW BIOPSY NEEDLE, JAMSHIDI, BENT DURING THE BONE MARROW BIOPSY PROCEDURE. FAULTY NEEDLES. CONTINUES TO BE AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546221 CUSTOM HEALTHCARE SYSTEMS ASPIRATION TRAY OJT CUSTOM HEALTHCARE SYSTEMS, INC. 66128

    Patients

    Seq Age Sex Outcome Treatment
    1 14965 DA Male