BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-ANIM AIRLIFE¿

    MDR report key: 22714290 · Received August 5, 2025

    Report

    Report Number
    22714290
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 17, 2025
    Report Date
    July 23, 2025
    Manufacturer
    AIRLIFE FINLAND OY
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRODUCT MFG#001505, LOT#0004295246; TEE ADAPTER FOUND TO BE TOO SMALL TO ALLOW FIT OF NEBULIZER. ALL OTHER LOTS IN SUPPLY ROOM HAVE NORMAL FIT. WHEN LOOKING AT THE VENDOR CATALOG, THERE IS ONE THAT IS 18MM AND ONE THAT IS 15MM. IT APPEARS THAT PERHAPS THE 15MM PRODUCT WAS PUT INTO AND LABELED AS THE 18MM, EXPLAINING THE FAILURE TO FIT. [DATE REDACTED] INFORMATION SUPPLIED TO VENDOR REP [REDACTED] AS WELL AS ALL PRODUCT IDS AND DESCRIPTION OF PROBLEM (ALL CAME IN VIA EMAIL). [DATE REDACTED] MATERIALS RETRIEVING PRODUCT FOR RETURN TO VENDOR. [DATE REDACTED] SAMPLE COLLECTED. [DATE REDACTED] EMAILED [REDACTED] AND [REDACTED] AND [REDACTED]. [DATE REDACTED] MAILED ON UPS TRK# [UNITED PARCEL SERVICE TRACKING NUMBER REDACTED]. MANUFACTURER RESPONSE FOR T ADAPTER W MOUTHPIECE FOR ETT, T ADAPTER W MOUTHPIECE FOR ETT (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2652127 TRI-ANIM AIRLIFE¿ CONNECTOR, AIRWAY (EXTENSION) BZA AIRLIFE FINLAND OY 001505 0004295246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown