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

Catalog Number	100/199/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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 the device was leaking.The cuff was checked before anesthesia and was then tight.On one occasion, a leak occurred approximately 2 hours into the operation and the other just before awakening.As the operation was complete, the patient's tidal volumes became smaller and smaller and within a few minutes they were extremely small and the ventilator alarmed for apnea.Manual ventilation was used but the patient was breathing from mouth.The cuff pressure was then less than 10.The cuff pressure was increased to 30 and within a few minutes dropped back to 10.The patient's saturation never fell below 97.Upon inspection of the tube, the leakage was identified at the point where the cuff is welded or glued to the tube.During a later inspection, the cuff was tight.There was patient involvement, but no injury.
Additional Manufacturer Narrative
D9 - date returned to mfg: 2/17/2026.H3 and h6 codes - updated one used device was returned for investigation.The device was visually inspected and there were no damages or anomalies observed.One (1) customer photo and one (1) video were returned showing cuff leakage at the proximal weld.During the functional testing, the trach tube cuff was inflated with air using the returned syringe.The trach tube was then submerged underwater to facilitate leak detection.The leak originated from the trach tube cuff weld (proximal).The complaint of leakage can be confirmed.The probable cause is due to a cuff welding error during manufacturing.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL 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: 24401130
• Report Number: 3012307300-2026-01532
• Device Sequence Number: 10113787
• Product Code: BTR
• UDI-Device Identifier: 55019315022324
• UDI-Public: (01)55019315022324(17)300121(10)6084220
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/21/2026

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: 100/199/070
• Device Lot Number: 6084220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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