BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM HEALTHCARE SYSTEMS, INC

    MDR report key: 22104885 · Received May 29, 2025

    Report

    Report Number
    22104885
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 2, 2025
    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

    PATIENT PRESENTED FOR BONE MARROW BIOPSY. WAS ABLE TO PERFORM ASPIRATION SUCCESSFULLY. UPON INSERTING CORE CATCHER INTO CORE BIOPSY NEEDLE, THIS NP [NURSE PRACTITIONER] WAS ABLE TO SUCCESSFULLY CLICK THE CATCHER INTO PLACE. ABLE TO TWIST CATCHER CLOCKWISE AND COUNTERCLOCKWISE TO LOOSEN SAMPLE. HOWEVER, UPON REMOVING CATCHER FROM CORE BIOPSY NEEDLE, MET LOTS OF RESISTANCE. UPON PULLING THE CATCHER OUT COMPLETELY, NOTICED THE BOTTOM OF THE CATCHER WHICH CONTAINED SAMPLE WAS TWISTED AND BENT. ABLE TO SUCCESSFULLY TRANSFER CORE SAMPLE FROM CATCHER INTO SPECIMEN CONTAINER WITH MEASURING TOOL, HOWEVER HAD TO APPLY LOTS OF PRESSURE TO DO SO GIVEN THE INSTRUMENT WAS TWISTED AND BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703673 CUSTOM HEALTHCARE SYSTEMS, INC ASPIRATION TRAY OJT MANUS MEDICAL, LLC 3805396 68830

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female