BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOJECT SAFETY SYRINGE W/SAFETY SHIELD AND NEEDLE

    MDR report key: 32300 · Received April 26, 1996

    Report

    Report Number
    MW1008963
    Event Type
    Injury
    Date Received
    April 26, 1996
    Date of Event
    October 26, 1994
    Report Date
    April 18, 1996
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THREE REGISTERED NURSES HAVE INCURRED A NEEDLE STICK WHILE SLIDING SAFETY SHEATH UP AFTER GIVING AN IMMUNIZATION. THIS HAS OCCURRED IN THE SAME SMALL DEPT OVER AN 18-MONTH PERIOD. THEY FEEL THAT THE SHEATH WAS STICKING OR IN SOME OTHER WAY HARD TO SLIDE. ALL THREE INCIDENTS OCCURRED DURING IMMUNIZATION CLINICS. FOLLOWING EXPOSURES, RPTR'S BODY SUBSTANCE EXPOSURE PROTOCOL WAS FOLLOWED AND THE EMPLOYEES HAVE ON-GOING FOLLOW UP IN THE OCCUPATIONAL HEALTH CLINIC. THESE NURSES FELT THERE COULD BE SOME DESIGN IMPROVEMENT SUCH AS A LIP TO PREVENT THE HAND FROM SLIPPING OFF THE SAFETY SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT SAFETY SYRINGE W/SAFETY SHIELD AND NEEDLE SYRINGE, 3CC, 22 GA X 1" NEEDLE FMF SHERWOOD MEDICAL CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention