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

Catalog Number	100/179/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Dyspnea (1816); Tachycardia (2095); Swelling/ Edema (4577)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
The patient experiences severe shortness of breath that was not relieved, with a progressively increasing heart rate, gradually rising to 145 beats per minute.A re-examination of arterial blood gas analysis shows ph: 7.23, pco2: 77 mmhg, po2: 89 mmhg, indicating that the improvement in type ii respiratory failure since admission was not ideal.Considering the patient's poor cardiopulmonary function, an endotracheal intubation was immediately performed for ventilator-assisted breathing.Bronchoscopy revealed a considerable amount of yellow-white sticky sputum in the airway, obvious airway spasm, and mucosal congestion and edema.Suctioning caused easy bleeding.The ventilator frequently alarmed, and an air leak from the endotracheal tube was detected, so it was immediately removed and discontinued.A size 7 nasotracheal intubation was performed instead, and the patient was successfully resuscitated.

• 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.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24020335
• Report Number: 3012307300-2026-00250
• Device Sequence Number: 18439562
• Product Code: BTR
• UDI-Device Identifier: 15019315022135
• UDI-Public: (01)15019315022135(17)280701(10)4403645
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: 100/179/075
• Device Lot Number: 4403645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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: 62 YR
• Patient Sex: Male