BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROGEN® SOLO CONTINUOUS NEBULIZATION TUBE SET

    MDR report key: 17001674 · Received May 25, 2023

    Report

    Report Number
    17001674
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    April 18, 2023
    Report Date
    April 20, 2023
    Manufacturer
    AEROGEN LTD.
    Product Code
    CAF
    UDI-DI
    05391517930405
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PHARMACY STAFF REPORTING THAT THEY HAVE RECENTLY NOTICED LEAKING FROM THE BACK OF AEROGEN SYRINGES USED TO PREPARE VELETRI FOR INHALATION. LEAKING SYRINGES WERE NOT DISPENSED AND THESE PRODUCTS WERE RE-MADE BEFORE SENDING FOR PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650346 AEROGEN® SOLO CONTINUOUS NEBULIZATION TUBE SET NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LTD. AG-AS3085 HM21009 05391517930405

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown