BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEROGEN® SOLO CONTINUOUS NEBULIZATION TUBE SET

    MDR report key: 23485283 · Received November 6, 2025

    Report

    Report Number
    23485283
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 3, 2025
    Manufacturer
    AEROGEN LIMITED
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AEROGEN SYRINGE IS A PROPRIETARY ITEM THAT ALLOWS DELIVERY OF CONTINUOUS AEROSOLIZED MEDICATIONS. WHEN PLACE INTO OPERATION THERE ARE 2 EVENTS OCCURRING. 1) WHEN DELIVERING MEDICATIONS, MEDICATION IS ¿SEEPING¿ ABOVE SYRINGE PLUNGER. 2) WHEN PRIMING SYRINGE THROUGH TUBING AFTER THE TUBING HAS BEEN PRIMED THE SYRINGE CONTINUES TO SIPHON ALL OF THE MEDICATIONS FROM SYRINGE (SYRINGE STOPPER MOVES INDEPENDENTLY). MANUFACTURER RESPONSE FOR AEROGEN 60 ML SYRINGE ¿ FOR USE IN CONTINUOUS NEBULIZATION, AEROGEN 60 ML SYRINGE (PER SITE REPORTER). MANUFACTURER ALSO STATED THIS IS A KNOWN ISSUE . EXERPT OF EMAIL ¿ FULL EMAIL AVAILABLE- ¿ ANOTHER CUSTOMER IN THE MIDWEST HAD A SIMILAR ISSUE AND WERE ABLE TO MOVE FORWARD WITHOUT FURTHER ISSUES FOLLOWING A COUPLE TWEAKS TO THEIR PRACTICE. THEIR PRACTICE INCLUDED PULLING THE PLUNGER COMPLETELY OUT OF THE BACK OF THE SYRINGE TO FILL THE SYRINGE AND REFRIGERATION OF THE SYRINGES AFTER BEING FILLED. ONCE THEY STARTED FILLING THE SYRINGES FROM THE TIP AND CEASED REFRIGERATION, THEY NO LONGER HAD ANY ISSUES. ARE EITHER OF THESE STEPS PART OF YOUR PROCESS? ¿ NONE OF THE DESCRIBED PRACTICES ARE PART OF THIS PROCESS. DEVICES ARE USED PER IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2693275 AEROGEN® SOLO CONTINUOUS NEBULIZATION TUBE SET NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LIMITED AG-AS3085 HM21502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention