BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMITH MEDICAL

    MDR report key: 3170196 · Received June 14, 2013

    Report

    Report Number
    MW5030533
    Event Type
    Other
    Date Received
    June 14, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SMITH MEDICAL ASD, INC
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INSULIN SYRINGES (1ML AND .5ML 28 GAUGE BY 1/2) LEAVING A REDDISH DISCOLORATION ON MEDICINE VIAL STOPPERS AFTER INSERTING AND REMOVING NEEDLE. VISIBLE DISCOLORATION OF SOME OF THE NEEDLES IS OBVIOUS. DATES OF USE: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270671 SMITH MEDICAL INSULIN SYRINGES FMF SMITH MEDICAL ASD, INC 4428-1 1891635
    270672 SMITH MEDICAL INSULIN SYRINGE FMF SMITH MEDICAL ASD, INC 4428-1 2381365
    270673 SMITH MEDICAL INSULIN SYRINGE FMF SMITH MEDICAL ASD, INC 4428-1 2459742
    270674 SMITH MEDICAL INSULIN SYRINGE FMF SMITH MEDICAL ASD, INC 4428-5 2463829

    Patients

    Seq Age Sex Outcome Treatment
    1