BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    #3 SYRINGE

    MDR report key: 247986 · Received October 26, 1999

    Report

    Report Number
    3023012-1997-00002
    Event Type
    Malfunction
    Date Received
    October 26, 1999
    Date of Event
    October 1, 1999
    Report Date
    October 19, 1999
    Manufacturer
    BIOJECT INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BIOJECT SYRINGE BROKE WHILE GIVING AN INJECTION. IT WAS ALLEGED THAT THE PT WAS SCRATCHED ON THE ARM AND THE NURSE WAS SKINNED ON THE NOSE. NO MEDICAL TREATMENT WAS REQUIRED FOR EITHER THE PT OR THE CAREGIVER. THERE IS NO TREND ASSOCIATED WITH THIS FAILURE MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 #3 SYRINGE NEEDLE-FREE SYRINGE FMF BIOJECT INC. #1S03100 51208-1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BIOJECTOR 2000 INJECTOR.