BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIKE ADAPTER

    MDR report key: 22755214 · Received August 8, 2025

    Report

    Report Number
    MW5174282
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    KJG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN PATIENT WAS RECEIVING STEM CELLS, RN ATTEMPTED TO PULL OUT SPIKE FROM FIRST BAG OF CELLS TO SPIKE THE SECOND BAG OF CELLS, AND THE SPIKE DISCONNECTED FROM THE TUBING. NEW SPIKE ACQUIRED AND CONNECTED TO TUBING. NO CELLS WERE LOST AND PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914039 SPIKE ADAPTER TUBE, TISSUE CULTURE KJG ORIGEN BIOMEDICAL, INC. REF 2S-P20 V23141

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male