BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO JET VENTILATION CATHETER

    MDR report key: 25119751 · Received May 7, 2026

    Report

    Report Number
    3041679947-2026-00003
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 16, 2026
    Report Date
    April 17, 2026
    Manufacturer
    PIPELINE MEDICAL PRODUCTS, LLC
    Product Code
    BTR
    UDI-DI
    00860014685200
    PMA / PMN Number
    K243579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED AND A REVIEW OF THE LHR WAS PERFORMED. DEVICE MANUFACTURED ACCORDING TO ALL REQUIREMENTS AND SPECIFICATIONS. NO ANOMALIES NOTED IN MANUFACTURING PROCESS, INCLUDING PACKAGING, LABELING, STERILIZATION OR MATERIALS USED. RETURNED PRODUCT WAS INSPECTED AND TESTED, NO DEFECTS NOTED AND THE DEVICE PERFORMED AS SPECIFIED. CAUSE OF ISSUE INDETERMINATE AT TIME OF REPORT.

    Description of Event or Problem · 0

    DURING AN SML PROCEDURE, JET VENTLATION WAS UTILIZED AND THE PATIENT PRESENTED WITH NECK EMPHYSEMA. CT AND UNILATERAL CHEST TUBE PLACED TO RULE OUT ANY ADDITIONAL BAROTRAUMA AND AS A PRECAUTION DUE TO PATIENT HEALTH STATUS AND AGE. NO PNEUMOTHROAX NOTED FROM CHEST TUBE. EMPHYSEMA RESOLVED PRIOR TO LEAVING OR SETTING. PATIENT KEPT OVERNIGHT, CHEST TUBE REMOVED WITHIN 24 HRS. PATIENT STABLE AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280420 AERO JET VENTILATION CATHETER JET VENTILATION TUBE, PRODUCT CODE: BTR BTR PIPELINE MEDICAL PRODUCTS, LLC AERO-SA1 1210514A (FROM SALES DATA) 00860014685200

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Unknown Hospitalization