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	100/199/085
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was reintubation due to persistent cuff leak and concern over cuff integrity, repeated inflation of pilot balloon and subsequent loss of pressure.There was patient involvement.There no patient harm.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The five samples received are new and sealed for analysis.Packaging seemed to be intact, and no damage was observed.Functional and visual tests were done, but the reported issue could not be duplicated.No deflation or leaks could be observed on any of the pieces.No non-conformities were identified that may have contributed to the reported complaint.

• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24235236
• Report Number: 3012307300-2026-00761
• Device Sequence Number: 8971579
• Product Code: BTR
• UDI-Device Identifier: 15019315022357
• UDI-Public: (01)15019315022357(17)300904(10)6128640
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K790313
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 100/199/085
• Device Lot Number: 6128640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown