BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA SAFE

    MDR report key: 369180 · Received December 26, 2001

    Report

    Report Number
    2029163-2001-00003
    Event Type
    Injury
    Date Received
    December 26, 2001
    Date of Event
    November 11, 2001
    Report Date
    December 26, 2001
    Manufacturer
    SAFETY SYRINGES INC.
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED TWO NEEDLE STICK INJURIES INVOLVING THE ULTRASAFE NEEDLE GUARD DEVICE. BOTH NURSES REPORTED THAT THE SHIELD (NEEDLE GUARD) STUCK WHEN THEY ATTEMPTED TO ACTIVATE IT.

    Description of Event or Problem · 2

    USER FACILITY REPORTED TWO NEEDLE STICK INJURIES INVOLVING THE ULTRASAFE NEEDLE GUARD DEVICE. BOTH NURSES REPORTED THAT THE SHIELD (NEEDLE GUARD) STUCK WHEN THEY ATTEMPTED TO ACTIVATE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58456 ULTRA SAFE ANTI-NEEDLE STICK SYRINGE FMF SAFETY SYRINGES INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other LOVENOX SYRINGE.
    2 32 YR Other LOVENOX SYRINGE.