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 Code	Aspiration/Inhalation (1725)
Date of Event	03/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was admitted to the orthopedic neurology department due to "right hip joint pain for 3 hours after falling".During hospitalization, pneumonia and respiratory failure occurred, which were assessed to be in line with the indications of mechanical ventilation support for invasive ventilation tracheal intubation therapy.The patient was transferred to the intensive care unit for invasive ventilation support using the tracheal intubation.On (b)(6) 2026, a leak was detected in the endotracheal tube cuff.Bronchoscopic examination revealed the aspiration of oropharyngeal secretions and gastric contents into the airway, thereby exacerbating the patient's pulmonary infection.The endotracheal tube was subsequently replaced.Following the replacement, no further aspiration of oropharyngeal secretions or gastric contents into the airway was observed.
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
D3 - updated.H3 and h6 ¿ updated.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.The device history file was reviewed.There were no non-conformities were identified that may have contributed to the reported complaint.If the product is returned, this complaint will be reopened for further investigation.

• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24794788
• Report Number: 3012307300-2026-03378
• Device Sequence Number: 9727734
• Product Code: BTR
• UDI-Device Identifier: 15019315022135
• UDI-Public: (01)15019315022135(17)280322(10)4385685
• 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,Followup
• Report Date (Section B): 06/16/2026

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: 4385685
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Male