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	100/199/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that on mar 16 (mon) the patient was intubated in the emergency room.A decrease in cuff pressure was observed on march 28, but since it was a holiday and it was difficult for a doctor to respond, air was injected using a cuff pressure gauge frequently, and use was continued.A ventilator leak alarm occurred on march 30, so the tube was replaced with a new one.Upon checking the tube after extubating, a leak was confirmed from the adhesive part at the top of the cuff.The event occurred during use.There was aftereffect reported.Frequent cuff pressure adjustments, tube replacements performed.The patient is experiencing o2 decrease, vap.The causality between the item and the disease cannot be denied.The patient had not recovered at the time of reporting.
Additional Manufacturer Narrative
D3 - mfr establishment name: corrected.H3 and h6 codes - updated.One used device was returned for investigation.No discrepancies related to the complaint were found during visual inspection.During the functional testing, it was observed that the cuff inflated however it deflated.Upon further inspection a channel was observed between the base of the cuff and the main tube.The complaint of leakage can be confirmed.The probable cause is due to a 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24932902
• Report Number: 3012307300-2026-04012
• Device Sequence Number: 20128694
• Product Code: BTR
• UDI-Device Identifier: 15019315022333
• UDI-Public: (01)15019315022333
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 100/199/075
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/08/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown