BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORMAL SALINE IV 0.9% FLUSH 10ML

    MDR report key: 897123 · Received July 23, 2007

    Report

    Report Number
    MW5003388
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 19, 2007
    Report Date
    July 23, 2007
    Manufacturer
    B BRAUN
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A 10 ML PREFILLED NORMAL SALINE SYRINGES MANUFACTURED BY B BRAUN ARE BROWN TINGED IN COLOR AND APPEAR TO HAVE PARTICULATE MATTER WITHIN THE SOLUTION. ALL LOTS ENDING IN SFR. DATES OF USE: TWENTY TWO DAYS IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORMAL SALINE IV 0.9% FLUSH 10ML NONE NGT B BRAUN 070601SFR

    Patients

    Seq Age Sex Outcome Treatment
    1 YR