BEUDAMED
    FDA Adverse Event Other Summary report: N

    SODIUM CHLORIDE INHALATION SOLUTION 3% UNIT-DOSE VIAL 4 ML

    MDR report key: 17631152 · Received August 25, 2023

    Report

    Report Number
    MW5144981
    Event Type
    Other
    Date Received
    August 25, 2023
    Manufacturer
    THE RITEDOSE CORPORATION
    Product Code
    CAF
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SODIUM CHLORIDE INHALATION SOLUTION 3% AND 7% FROM RITEDOSE PHARMACEUTICALS DO NOT HAVE THE STRENGTH INDICATED ON THE NEB ITSELF. AS A HOSPITAL THAT USES THIS MEDICATION, WE HAVE TO MANUALLY LABEL THE PRODUCT WITH A STICKER WHEN IT IS REMOVED FROM THE BOX TO DISPENSE TO PATIENTS OR TO ADC. HOWEVER, IF THE STICKER FALLS OFF OR IS OTHERWISE RENDERED UNREADABLE/UNSCANNABLE, THERE IS NO WAY FOR THE CLINICIAN TO KNOW WHAT STRENGTH THE PRODUCT IS. HTTPS://RITEDOSE.COM/WP-CONTENT/UPLOADS/2023/03/RDP SODIUMCHLORIDE-3-7PCT CARTONS.PDF (HTTPS://RITEDOSE COM/WP-CONTENT/UPLOADS/2023/03/RDP SODIUMCHLORIDE-3-7PCT CARTONS.PDF). ISMP IS A FEDERALLY CERTIFIED PATIENT SAFETY ORGANIZATION AND AN FDA MEDWATCH PARTNER. ISMP, 5200 BUTLER PIKE, PLYMOUTH MEETING, PA 19462; PHONE: 215-947-7797; EMAIL: [email protected]. SUBMISSION ID: (B)(4). REFERENCE REPORT: MW5144980.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999564 SODIUM CHLORIDE INHALATION SOLUTION 3% UNIT-DOSE VIAL 4 ML NEBULIZER (DIRECT PATIENT INTERFACE) CAF THE RITEDOSE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown