BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE WATER FOR IRRIGATION, USP

    MDR report key: 19143186 · Received April 18, 2024

    Report

    Report Number
    MW5154012
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    April 17, 2024
    Report Date
    April 17, 2024
    Manufacturer
    HALYARD/NURSE ASSIST, LLC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HALYARD BRAND STERILE WATER FOR IRRIGATION STATES ON THE PRODUCT LABEL: "OSMOLARITY CALV: 308 MOSMO/LITER". WHEN I REACHED OUT TO OWENS AND MINOR, THE PARENT COMPANY FOR HALYARD, THEIR RESPONSE WAS THIS: "THANK YOU FOR GETTING IN TOUCH. REGARDING YOUR INQUIRY BELOW, WE'VE IDENTIFIED AN ERROR IN THE ARTWORK AS YOU INITIALLY SUSPECTED. I CAN CONFIRM THAT THE PRODUCT INDEED HAS A MOSMOL/LITER READING OF 0, AND WE ARE CURRENTLY IN THE PROCESS OF UPDATING THE ARTWORK ACCORDINGLY." THERE HAVE BEEN NO NEGATIVE IMPACT TO PATIENTS THAT I AM AWARE OF. REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584348 STERILE WATER FOR IRRIGATION, USP DRESSING, WOUND, DRUG FRO HALYARD/NURSE ASSIST, LLC 23106631

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown