BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYR BD NED UFINE 0.5 ML 10'S 30G 1/2

    MDR report key: 3416331 · Received October 10, 2013

    Report

    Report Number
    MW5032273
    Event Type
    Injury
    Date Received
    October 10, 2013
    Date of Event
    September 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PER PT SOME OF HIS SYRINGES HAVE NO MARKINGS ON THEM OTHER THAN A FEW LINES, THERE ARE NO NUMBERS, ADV SHOULD HAVE UNITS MARKED FROM 10 TO 50 PER IMG ON BD WEBSITE OF THIS MDC, PER SPOUSE (WHO HAS BETTER VISION) ABOUT 4 OR 5 OUT OF A 100 HAVE NO NUMBERS JUST LINES, FROM TWO SEPARATE ORDERS WITH DIFFERENT LOTS (3168094 AND 3043367), DUE TO PT'S POOR VISION HE HAS INCORRECTLY DOSED HIMSELF LOOKING FOR NUMBERS THAT WEREN'T THERE. DOSE, FREQUENCY AND ROUTE USED: SUBCUTANEOUS. THERAPY DATES: TWICE DAILY. DIAGNOSIS FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516015 SYR BD NED UFINE 0.5 ML 10'S 30G 1/2 SYRINGE FMF BD 3168094
    516016 SYR BD NED UFINE 0.5ML 10'S 30G 1/2 SYRINGE FMF BD 3043367

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening