BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 12121287 · Received July 2, 2021

    Report

    Report Number
    MW5102286
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Report Date
    June 30, 2021
    Manufacturer
    COVIDIEN / MEDTRONIC PERFUSION SYSTEMS / MEDTRONIC INC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MAGELLAN 22 G 1 1/2" NEEDLE HUB POSSIBLE DEFECT. LOT: 912167, EXP: 03/31/2024 NEEDLE HUB SPLIT VERTICALLY WHEN ATTACHED TO SYRINGE LOT: 010437, EXP: 02/28/2025 CRACKED IN PIECES WHEN ATTACHED TO SYRINGE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009182 MAGELLAN SYRINGE, PISTON FMF COVIDIEN / MEDTRONIC PERFUSION SYSTEMS / MEDTRONIC INC 107483
    1009183 NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN / MEDTRONIC PERFUSION SYSTEMS / MEDTRONIC INC 912167

    Patients

    Seq Age Sex Outcome Treatment
    1