BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE COMFORT 1CC 5/16" 3LGA INSULIN SYRINGE

    MDR report key: 3101311 · Received May 5, 2013

    Report

    Report Number
    MW5030079
    Event Type
    Malfunction
    Date Received
    May 5, 2013
    Date of Event
    February 10, 2013
    Report Date
    May 5, 2013
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED SEVERAL BOXES OF SYRINGES FROM OUR PHARMACY AS A PRESCRIPTION. IN ONE OF THE 10CT BAGS A SYRINGE DID NOT HAVE A CAP ON IT AND THERE WAS NOT A LOOSE CAP IN THE BAG. IN ANOTHER BAG OF 1CC SYRINGES HE FOUND A 1/2 CC SYRINGE. DATES OF USE: (B)(6) 2013. REASON FOR USE: INSULIN INJECTION. DOSE: INSULIN. FREQUENCY: 5 TIMES DAILY, ROUTE: SQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195845 SURE COMFORT 1CC 5/16" 3LGA INSULIN SYRINGE NONE FMF ALLISON MEDICAL, INC. 21025

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other