BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSURE INSULIN SYRINGE 1CC 31 G 5/16"

    MDR report key: 1230106 · Received November 12, 2008

    Report

    Report Number
    MW5008970
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 12, 2008
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHEN DRAWING UP INSULIN, EVERYTHING SEEMED NORMAL. AT TIME OF INJECTION, INSULIN SPILLING ONTO SKIN-PULLED SYRINGE AWAY FROM SKIN AND NEEDLE RETRACTED INTO SYRINGE. UNAWARE IF NEEDLE BROKE IN INJECTION SITE. THREE TIMES PRIOR TO THIS-THE NEEDLE BROKE OFF INSIDE THE INSULIN VIAL. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: INSULIN INJECTION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE INSULIN SYRINGE 1CC 31 G 5/16" NONE FMF A07001

    Patients

    Seq Age Sex Outcome Treatment
    1