BEUDAMED
    FDA Adverse Event Summary report: N

    SALINE FLUSH INJECTION

    MDR report key: 493051 · Received August 11, 2003

    Report

    Report Number
    MW4003574
    Date Received
    August 11, 2003
    Report Date
    August 11, 2003
    Manufacturer
    EXCELSIOR MEDICAL CORP
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NURSE DESCRIBED A # OF PTS THAT HAVE BECOME NAUSEATED AFTER HAVING THEIR LINES FLUSHED WITH THE PREPACKAGED SODIUM CHLORIDE FLUSH. UPON INSPECTION OF THE PRODUCT, THAT IS OPENING THE PRODUCT & DISPENSING INTO A SOUFFLE CUP THE PRODUCT SMELLED VERY HEAVILY OF ALCOHOL. THE PRODUCT IS SUPPOSED TO BE PRESERVATIVE FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE FLUSH INJECTION 0.9% 60 X 3 CC BOX FMF EXCELSIOR MEDICAL CORP * 10-402

    Patients

    Seq Age Sex Outcome Treatment
    1 *