BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIRLIFE BROSELOW TAPE

    MDR report key: 23771676 · Received December 10, 2025

    Report

    Report Number
    MW5180289
    Event Type
    Other
    Date Received
    December 10, 2025
    Manufacturer
    SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE
    Product Code
    OKI
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE NEW AIRLIFE BROSELOW TAPE 2025 REVISION 3 CONTAINS TWO ERRORS ON THE BACK OF THE COVER PAGE. UNDER THE PRE- RSI/RSA NEUROMUSCULAR BLOCKERS SECTION THE VECURONIUM IV/IO SAYS 0.1 MG/ML WHEN IT SHOULD BE 0.1 MG/KG. IN ADDITION, UNDER TOXICOLOGY THE FLUMAZENIL IV/IO IS LISTED AS 0.1 MG/KG WHEN IT SHOULD BE 0.01 MG/KG. ACCORDING TO CORRESPONDENCE WITH SOMEONE IN THE MSOS BLOG THE COMPANY CLAIMS THE VECURONIUM IS NOT AN ERROR, I DISAGREE. THEY DO AGREE THAT THE FLUMAZENIL IS AN ERROR BUT HAVE NO PLANS TO RECALL. I BELIEVE WITH BOTH THESE ERRORS A RECALL SHOULD OCCUR. AS A HOSPITAL SYSTEM WE HAVE NO CHOICE BUT TO EITHER CONTINUE TO USE 2019 VERSIONS OR HAVE TO MAKE CORRECTIONS ON OUR OWN. IN THE ATTACHMENT I'VE SHOWN ONE OF OUR TAPES THAT HAD TO BE CORRECTED BECAUSE THEY THREW ALL THE 2019 VERSIONS WHEN THIS VERSION WAS RELEASED. CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6). SUBMISSION ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554716 AIRLIFE BROSELOW TAPE EMERGENCY RESPONSE SAFETY KIT OKI SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FLUMAZENIL.| VECURONIUM BROMIDE.