BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURE COMFORT SYRINGES

    MDR report key: 748867 · Received July 28, 2005

    Report

    Report Number
    MW1036185
    Event Type
    Other
    Date Received
    July 28, 2005
    Date of Event
    July 26, 2005
    Report Date
    July 28, 2005
    Manufacturer
    ALLISON MEDICAL INC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED ME CONCERNING PARTICLES FLOATING IN SYRINGE WITH INSULIN. PT BROUGHT IN BOTTLE OF INSULIN & SYRINGE. PARTICLES APPEAR DARK IN COLOR AND IN MY OPINION CANNOT BE ATTRIBUTED TO CORING OF THE INSULIN BOTTLE. THE PATIENT WAS GIVEN A NEW BOTTLE OF INSULIN AND REMAINING SYRINGES IN HER POSSESSION WERE EXAMINED. SHE ONLY NOTICED THE PARTICLES AFTER TRYING TO PUSH AIR OUT OF THE SYRINGE AFTER DRAWING UP DOSE FROM THE BOTTLE. UNABLE TO PUSH THE AIR OUT, SHE NOTED THE PARTICLES FLOATING IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE COMFORT SYRINGES INSULIN SYRINGES FMF ALLISON MEDICAL INC 1CC 29 GAUGE 1/2" 41004

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other NOVOLIN N INSULIN LOT #RZF0056