MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ENDOTRACHEAL TUBES; BASIC ENDOTRACHEAL TUBE, SINGLE USE

Catalog Number	100/179/080
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2025
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 reportable information becomes available.
Event or Problem Description
It was reported that approximately two hours after intubation, leakage was observed from the cuff, and the device was subsequently replaced.The event involved a patient, but no injury was reported.
Additional Manufacturer Narrative
H3: the device was received for evaluation.A lot history review could not be conducted because no lot number was identified.As received, no damage or anomalies were observed.Visual and functional testing was performed to replicate clinical use, during which the tracheal tube cuff was inflated using an icu medical provided syringe.The cuff initially inflated but subsequently deflated.The cuff was reinflated and placed in a water bath, where air leakage was observed originating between the base of the cuff and the main tube.Further inspection identified a channel between the base of the cuff and the main tube.The complaint of air leakage was confirmed.The probable cause was determined to be a welding error during manufacturing in tijuana.
Additional Manufacturer Narrative
D2b - procode - corrected.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• Common Device Name: BASIC ENDOTRACHEAL TUBE, SINGLE USE
• 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: 23878340
• Report Number: 3012307300-2025-13687
• Device Sequence Number: 21233723
• Product Code: BTR
• UDI-Device Identifier: 15019315022142
• UDI-Public: (01)15019315022142
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2026

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: 100/179/080
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 01/21/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/27/2026; 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 55 YR
• Patient Sex: Female