BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED

    MDR report key: 23273641 · Received October 10, 2025

    Report

    Report Number
    1314417-2025-00072
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    July 16, 2025
    Report Date
    September 18, 2025
    Manufacturer
    SUNMED LLC
    Product Code
    BTR
    PMA / PMN Number
    K042683
    Removal / Correction Number
    MW5174207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 10 OCT 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT - (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

    Description of Event or Problem · 0

    THE ENDOTRACHEAL TUBE MADE BY SUNMED LLC, CUFFED ENDOTRACHEAL TUBE, SIZE 2.5. A NEWER SHIPMENT WILL NOT ACCEPT A SIZE 5/6 SUCTION CATHETER. THIS HAS BEEN A CHANGE FROM PRIOR PRODUCT AND IS A PROBLEM AS ENDOTRACHEAL TUBE OBSTRUCTION CAN CAUSE DEATH. PHOTO 1 HAS THE OLD ETT WITH ABILITY TO PASS SUCTION, PHOTOS 2 AND 3 DEMONSTRATE THAT THE SUCTION WILL NOT PASS BEYOND THE MID PORTION OF THE ETT WHERE THE PILOT BALLOON IS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651448 SUNMED E/T TUBE CUFFED 2.5MM 10FR BTR SUNMED LLC 1-7333-25 2402010378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other