BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN HYPODERMIC SAFETY NEEDLE 25 GAUGE 5/8"

    MDR report key: 9693693 · Received February 10, 2020

    Report

    Report Number
    MW5092889
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 28, 2020
    Report Date
    February 6, 2020
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MAGELLAN 3ML SYRINGE WITH HYPODERMIC SAFETY NEEDLE SLIGHTLY EXPOSED AT TOP OF SAFETY CAP. CAP WOULD NOT CLOSE FULLY AND ENCAPSULATE NEEDLE EMPLOYEE STUCK WITH USED NEEDLE AND UNDERWENT EXPOSURE PROTOCOL. ALSO HAPPENED AGAIN ON (B)(6) 2020 WITH LOT 933654. NO EMPLOYEE INJURED WITH THIS MALFUNCTION. FDA SAFETY REPORT ID # (B)(4). FDA RECEIVED DATE: 02/06/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149980 MAGELLAN HYPODERMIC SAFETY NEEDLE 25 GAUGE 5/8" NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 933654
    149981 MAGELLAN HYPODERMIC SAFETY NEEDLE 25 GAUGE 5/8" NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 922102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other