BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIKE ADAPTER - TWO SPIKES TO ONE SPIKE PORT WITH 20CM SCD TUBING AND PINCH CLAM

    MDR report key: 22234950 · Received June 17, 2025

    Report

    Report Number
    MW5171579
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 6, 2025
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    KJG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE WERE MECHANICAL COMPLICATIONS WITH THE GRAVITY TUBING AND SPIKE ADAPTER USED DURING THE PREPARATION AND ADMINISTRATION OF A HEMATOPOIETIC STEM CELL TRANSPLANT. WHEN THE GRAVITY TUBING WAS BEING PRIMED WITH NORMAL SALINE, THE BEDSIDE RN NOTED AN UNUSUALLY SLOW DRIP RATE, WHICH DID NOT IMPROVE WITH COMPLETELY OPENING THE ROLLER CLAMP. (THERE NEEDS TO BE FREE FLOW OF FLUID THROUGH THIS TUBING WHEN STEM CELLS ARE INFUSING TO AVOID CLUMPING OF CELLS OR OTHER ADVERSE EFFECTS.) THIS TUBING WAS DISCARDED AND REPLACED WITH A NEW SET OF GRAVITY TUBING, WHICH DRIPPED APPROPRIATELY. PRODUCT INFORMATION: BD SMARTSITE GRAVITY SET, NEEDLE-FREE VALVE (VENTED/NONVENTED) REF 41173E (ALARIS PRODUCTS) LOT H37041173E1D (BOTH SETS OF GRAVITY TUBING USED WERE FROM THIS LOT.) DURING THE STEM CELL INFUSION, ONE SIDE OF THE SPIKE ADAPTER (A Y-SHAPED PIECE OF TUBING THAT IS USED TO SPIKE THE SMALL FLUID BAGS & THE STEM CELL BAGS) HAD ONE SIDE THAT WAS NOT CLAMPING. THE BEDSIDE RN HAD TO USE A HEMOSTAT TO CLAMP THAT SIDE WHEN IT WAS NOT SUPPOSED TO BE DRIPPING. SPIKE ADAPTER - TWO SPIKES TO ONE SPIKE PORT WITH 20CM SCD TUBING AND PINCH CLAMPS REF 2S-P20 LOT V23644 THE STEM CELLS WERE ABLE TO BE INFUSED WITH NO ADVERSE EVENTS. THE PATIENT RECEIVED THEIR ENTIRE DOSE OF STEM CELLS WITHOUT INCIDENT. UNIT LEADERSHIP AND NURSE EDUCATOR WERE NOTIFIED OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34389 SPIKE ADAPTER - TWO SPIKES TO ONE SPIKE PORT WITH 20CM SCD TUBING AND PINCH CLAM TUBE, TISSUE CULTURE KJG ORIGEN BIOMEDICAL, INC. V23644

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention