BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM HEALTHCARE SYSTEMS, INC

    MDR report key: 18102937 · Received November 9, 2023

    Report

    Report Number
    18102937
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 7, 2023
    Manufacturer
    CUSTOM HEALTHCARE SYSTEM, 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

    DR. WAS PERFORMING A BONE MARROW BIOPSY ON THIS PATIENT AND THE ASPIRATE NEEDLE WAS FAULTY (SLIGHT BEND ON THE TIP) NEEDLE REMOVED AND NEW ASPIRATE NEEDLE USED TO COMPLETE THE BONE MARROW BIOPSY. I HAVE THE FAULTY NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110758 CUSTOM HEALTHCARE SYSTEMS, INC ASPIRATION TRAY OJT CUSTOM HEALTHCARE SYSTEM, INC 3805396 20230612, 20236014

    Patients

    Seq Age Sex Outcome Treatment
    1 7300 DA Female