BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT LIFESHIELD

    MDR report key: 9238700 · Received October 25, 2019

    Report

    Report Number
    9238700
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    May 22, 2019
    Report Date
    September 30, 2019
    Manufacturer
    COVIDIEN LLC
    Product Code
    NKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN MONOJECT 1ML TUBERCULIN SAFETY SYRINGE WITH NEEDLE, 28G X 1/2" IN A SEALED PACKAGE. NURSE OBSERVED THAT NEEDLE WAS BENT (ABLE TO SEE IT WHILE IN THE SEALED PACKAGE). THE NEEDLE WAS NOT USED ON A PATIENT. DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034998 MONOJECT LIFESHIELD NEEDLE, HYPODERMIC NKK COVIDIEN LLC

    Patients

    Seq Age Sex Outcome Treatment
    1