BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORMAL SALINE

    MDR report key: 1111843 · Received August 12, 2008

    Report

    Report Number
    MW5007980
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 12, 2008
    Manufacturer
    BD
    Product Code
    NGT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT'S FATHER FLUSHED CENTRAL LINE WITH NORMAL SALINE FLUSH -10MLS-. WHILE FLUSHING PT, DAD NOTICED THAT HIS FACE WAS "BEET RED" AND APPEARED TO BE PUFFY LOOKING. PT ALSO IMMEDIATELY HAD AN EPISODE OF DIARRHEA AND WAS CHOKING AND GAGGING. DAD HAD ANOTHER BRAND OF NORMAL SALINE FLUSH IN THE HOME FROM ANOTHER COMPANY AND FLUSHED WITH THAT BRAND WITHOUT A REACTION. ADVERSE EVENT LASTED ABOUT 4 MINUTES AND RESOLVED EXCEPT THAT THE PT APPEARED LETHARGIC TO THE FATHER. DOSE OR AMOUNT: 10ML. FREQUENCY: AS NEEDED. ROUTE: IV BOLUS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: FLUSHING CENTRAL LINE. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORMAL SALINE SALINE 0.9% NGT BD 7094085

    Patients

    Seq Age Sex Outcome Treatment
    1 Other