MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/199/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was stated in the report that during the leak test, the minor leakage was not detected.However, within 24 hours, the patient experienced a drop in oxygen saturation while on the ventilator.Based on the investigation, a ventilation leak from the ett was identified.After reintubation and monitoring of the ett cuff using water, it was found that the ett cuff had been leaking.The event occurred at hospital while in use with patient.There was no patient harm/adverse event reported.
Additional Manufacturer Narrative
No samples were returned, only one video was received.The video depicts a flowline product going through an underwater leak test.Bubbles can be observed as air leaks from the cuff balloon, which can confirm the defect reported.A probable cause could be due to the thickness of the cuff material, which is a parameter that has been evaluated and changed as of september 2025.With changes implemented there is better accuracy on the measurement of the cuff¿s wall thickness, which leads to an improvement in the welding process of cuff.Since the piece reported was manufactured in january 2025, the improvement had not yet been implemented.Although the manufacturing date indicates a reasonable cause for the defect, no definitive cause can be confirmed as no samples were received.

• Brand Name: PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23786537
• Report Number: 3012307300-2025-13421
• Device Sequence Number: 13379620
• Product Code: BTR
• UDI-Device Identifier: 15019315022333
• UDI-Public: (01)15019315022333(17)300110(10)6074961
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 100/199/075
• Device Lot Number: 6074961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown