BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALINE FLUSH INJECTION

    MDR report key: 255696 · Received November 24, 1999

    Report

    Report Number
    MW4002652
    Event Type
    Malfunction
    Date Received
    November 24, 1999
    Report Date
    November 24, 1999
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PREDRAWN STERILE FLUSH SYRINGE FOUND TO HAVE YELLOW, POWDERING SUBSTANCE IN IT. SECONDARY FIRM: THE MANUFACTURER'S IDENTITY HAS NOT BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE FLUSH INJECTION SODIUM CHLORIDE 0.9% FOZ EXCELSIOR MEDICAL CORP. NA 043001
    2 SALINE FLUSH INJECTION SODIUM CHLORIDE 0.9% FOZ * NA 043101

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO