BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROGEN SOLO

    MDR report key: 11398701 · Received March 2, 2021

    Report

    Report Number
    11398701
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    January 27, 2021
    Report Date
    February 4, 2021
    Manufacturer
    AEROGEN LTD.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INHALED EPOPROSTENOL HUB BREAKING OFF WHEN RT GOES TO REMOVE CAP. THIS MAY BE A MANUFACTURING DEFECT OF THE AEROGEN SYRINGE. RT WAS ABLE TO UTILIZE THE SYRINGE DUE AT 1730.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295710 AEROGEN SOLO NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LTD. MH19166

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA