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 Codes	Cardiac Arrest (1762); Respiratory Arrest (4461); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 phone number: (b)(6).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that an 87-year-old male patient experienced sudden respiratory and cardiac arrest.The doctor performed tracheal intubation at the bedside during emergency resuscitation.During the procedure, an air leak was found in the tracheal tube, and the tracheal tube was immediately replaced to complete the resuscitation efforts.The patient was later transferred to the icu for continued treatment.
Additional Manufacturer Narrative
B1 and b2 - updated.D3 - updated.H6 ¿ updated.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.The device history file was reviewed.There were no non-conformities were identified that may have contributed to the reported complaint.If the product is returned, this complaint will be reopened for further investigation.Initially, the event was incorrectly classified as a serious injury.Upon review, the findings indicate that the event was limited to a device malfunction with no associated injury.Accordingly, the report has been revised and classified as a malfunction.

• 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: 24872864
• Report Number: 3012307300-2026-03381
• Device Sequence Number: 10020145
• Product Code: BTR
• UDI-Device Identifier: 15019315022333
• UDI-Public: (01)15019315022333(17)290901(10)6051895
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 100/199/075
• Device Lot Number: 6051895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male