BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE NORMAL

    MDR report key: 997187 · Received February 7, 2008

    Report

    Report Number
    MW5005379
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    January 7, 2008
    Report Date
    February 7, 2008
    Manufacturer
    BECTON, DICKINSON AND CO. (BD)
    Product Code
    NGT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NON VIABLE GRAM POSITIVE COCCI IN 5ML TUBE STERILE SALINE. THIS CAUSED AN ERROR IN READING GRAM STAIN. BODY FLUIDS AND TISSUE REPORTED OUT IN ERROR. GRAM POSITIVE COCCI SEEN ON GRAM STAIN NEVER GREW ON PT'S CULTURES. DOSE OR AMOUNT: #1: SALINE NORMAL; #2: 0.85% 5ML TUBES. FREQUENCY: PRODUCT # 221819. DATE OF USE: 2007- 2008. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE NORMAL NONE NGT BECTON, DICKINSON AND CO. (BD) 7310714

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other