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	100/199/080J
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
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 information becomes available.
Event or Problem Description
It was reported that a leak was observed in the endotracheal tube with a soft seal cuff approximately four hours after intubation, which required re-intubation.There was no reported patient harm or adverse event.
Additional Manufacturer Narrative
Two units were received for evaluation in used condition, seven new units were received of lot #6058800, and 24 new units of lot #6112093.As received, there was no physical damage or other anomalies observed on the 31 new and the 2 used samples received.Functional testing was performed and on the two used samples, the cuff inflated successfully but showed signs of deflation after one minute.The 31 new returned samples were tested in the same manor; no leaks were observed.The customer complaint of a leakage appeared to occur from the adhesive part on the upper cuff and the probable cause is due to an inconsistent weld around the tubing.A device history review was performed and no nonconformances were identified.

• 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: 23937408
• Report Number: 3012307300-2025-13927
• Device Sequence Number: 13143590
• Product Code: BTR
• UDI-Device Identifier: 15019315022340
• UDI-Public: (01)15019315022340(17)291028(10)6058800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (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): 04/10/2026

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: Lay User/Patient
• Device Catalogue Number: 100/199/080J
• Device Lot Number: 6058800
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown