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

Catalog Number	100/179/070
Medical Device Problem Codes	Decrease in Pressure (1490); Ventilation Problem in Device Environment (3027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the report that a 77-year-old male patient born on (b)(6) 1948, diagnosed with chronic obstructive pulmonary disease with acute lower respiratory tract infection.On december 11, it was noted that there were obvious wheezing sounds.To remove deep-seated phlegm and clear the airway, a bedside fiberoptic bronchoscopy was performed.The bronchoscope was inserted via nasal tracheal intubation.The tracheal tube packaging was opened, and the integrity of the tracheal tube cuff was tested, revealing a cuff leak air.The tracheal tube was immediately replaced, the procedure proceeded smoothly, and the cuff pressure of the tracheal tube was normal during testing.On december 12, during the ward round, the patient's vital signs were stable.Upon checking the tubes, it was found that the tracheal tube cuff pressure was below the normal value.The tracheal tube cuff was reinflated, and after observing the cuff for 5 minutes, the pressure was still below normal.The doctor was immediately notified to replace the tracheal tube, and the procedure went smoothly.No patient harm was reported.
Additional Manufacturer Narrative
H3: 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
H3/h6: no product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24059548
• Report Number: 3012307300-2026-00329
• Device Sequence Number: 9465928
• Product Code: BTR
• UDI-Device Identifier: 15019315022128
• UDI-Public: (01)15019315022128(17)290801(10)6031608
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: UNKNOWN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 100/179/070
• Device Lot Number: 6031608
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Male