BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN- LOCK SWABABLE 2 GANG 4 WAY HIGH FLOW STOPCOCK

    MDR report key: 21936492 · Received April 30, 2025

    Report

    Report Number
    MW5169671
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    April 16, 2025
    Report Date
    April 24, 2025
    Manufacturer
    CODAN US CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS FOUND (AFTER MOVING OUT OF MRI SCANNER AND UNWRAPPING THE BED STRAP) THAT THE PRE-ASSEMBLED IV TUBING WAS DISCONNECTED AT THE T-PIECE MOST PROXIMAL TO THE PATIENT. THERE WAS ~100 CC IV FLUID AND SOME MINIMAL BLOOD ON THE PATIENT GOWN AND BLANKET HIDDEN BY THE MRI TABLE STRAP. THIS WAS UNRECOGNIZED AS THE PATIENT WAS IN THE BORE OF THE SCANNER. THE CONSEQUENCE OF THIS DISCONNECT WAS THAT THE MRI CONTRAST ADMINISTERED MORE DISTAL IN THE IV SET WAS DELIVERED TO THE TABLE AND NOT INTRAVENOUSLY. THIS REQUIRED US TO REINTUBATE THE PATIENT, ADMINISTER THE CONTRAST, AND SCAN FOR AN ADDITIONAL 40 MINUTES UNDER GA. I WAS TOLD BY THE CRNA THAT THESE DISCONNECT AT THIS LOCATION QUITE FREQUENTLY AND THEY CONSTANTLY CHECK THAT LOCATION FOR LOOSE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191901 SWAN- LOCK SWABABLE 2 GANG 4 WAY HIGH FLOW STOPCOCK SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORP. 241121-00003629

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Required Intervention