BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROSELOW RAINBOW TAPE

    MDR report key: 23771755 · Received December 10, 2025

    Report

    Report Number
    MW5180294
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 5, 2025
    Manufacturer
    SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE
    Product Code
    OKI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AIRLIFE BRAND, REVISION 3, PRINT VERSION BROSELOW RAINBOW TAPE HAS TWO DOSING ERRORS, ONE SERIOUS. THIS IS THE TAPE THAT REPLACED THE RECALLED TAPE FROM MAY. VECURONIUM IV/IO (INTRAVENOUS (IV) /INTRAOSSEOUS (IO)) IS SHOWN AS 0.1 MG/ML INSTEAD OF 0.1 MG/KG. MORE CONCERNING IS THAT FLUMAZENIL IV/PO IS SHOWN AS 0.1 MG/KG INSTEAD OF 0.01 MG/KG. WE REPORTED THIS TO THE MANUFACTURER BUT WERE TOLD THERE ARE NO PLANS TO UPDATE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554721 BROSELOW RAINBOW TAPE EMERGENCY RESPONSE SAFETY KIT OKI SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown