BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALINE FLUSH INJECTION

    MDR report key: 268480 · Received February 23, 2000

    Report

    Report Number
    MW4002715
    Event Type
    Malfunction
    Date Received
    February 23, 2000
    Date of Event
    February 3, 2000
    Report Date
    February 3, 2000
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT DOES NOT SPECIFY THE LOT NUMBER ON THE INDIVIDUAL PRE-FILLED SYRINGE OR THE BOX CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE FLUSH INJECTION SODIUM CHLORIDE 0.9% 6 X 3CC BOX FOZ EXCELSIOR MEDICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO