BEUDAMED
    FDA Adverse Event Summary report: N

    PERCUTANEOUS STIK

    MDR report key: 17053 · Received October 21, 1994

    Report

    Report Number
    MW1003752
    Date Received
    October 21, 1994
    Manufacturer
    BYRON MEDICAL
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN RECEIVED, THIS SYRINGE HAD PARTICLES OF METAL IN THE GLASS CHAMBER. RPTR ATTEMPTED TO CLEAN OFF THE PARTICLES BUT FOUND THEY WERE TOO UBIQUITOUS AND TOO DIFFICULT TO CLEAN OUT. RPTR RETURNED THIS SYRINGE TO MFR BECAUSE OF FEAR OF INJECTING SMALL METALLIC PARTICLES INTO HIS PTS. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS STIK SYRINGE FMF BYRON MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 *