BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM HEALTHCARE SYSTEMS, INC

    MDR report key: 12646903 · Received October 18, 2021

    Report

    Report Number
    12646903
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 20, 2021
    Report Date
    September 28, 2021
    Manufacturer
    CUSTOM HEALTHCARE SYSTEMS, INC.
    Product Code
    OJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BONE MARROW BIOPSY KIT FAILURE RESULTING IN COMPROMISED SPECIMEN. WHILE PERFORMING A BONE MARROW BIOPSY ON THIS PATIENT, THE CUTTING NEEDLE TWISTED TO SUCH AN EXTENT THAT IT WAS BENT AND CLOSED OFF AND THE BONE MARROW CORE COULD NOT BE REMOVED IN STANDARD FASHION. MUCH OF THE CORE BECAME FRAGMENTED AND CRUSHED WHILE TRYING TO FREE IT FROM THE CUTTING NEEDLE, AND THE REMAINING CORE WAS NOT ABLE TO BE INTERPRETED BY THE PATHOLOGIST. THE PATIENT MAY REQUIRE THE PROCEDURE TO BE REPEATED DUE TO THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543615 CUSTOM HEALTHCARE SYSTEMS, INC ASPIRATION TRAY OJT CUSTOM HEALTHCARE SYSTEMS, INC. 3805396 207957

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA