BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROGEN SOLO CONTINUOUS NEBULIZATION TUBE SET

    MDR report key: 19857972 · Received July 29, 2024

    Report

    Report Number
    19857972
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 8, 2024
    Manufacturer
    AEROGEN LTD.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE RUBBER STOPPER/PLUNGER ON THE SYRINGE IS GETTING CAUGHT BELOW THE DOSAGE LINE, NOT ALLOWING FOR FULL DOSE OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255163 AEROGEN SOLO CONTINUOUS NEBULIZATION TUBE SET NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LTD. AG-AS3085 21J28018

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown