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	100/199/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a sign of gas leakage after the tracheal tube was inserted to patient for mechanical ventilation.The tracheal tube had to be removed and replaced with a new one to maintain ventilatory support.Examination of the removed tracheal tube found gas leakage from the junction between the balloon and tube body.Leakage of tracheal tube balloon may lead to insufficient ventilatory support and increase risk of aspiration for patient.Replacement of tracheal tube is a risk as difficult intubation may encounter.There was patient involvement and there was no patient harm.
Additional Manufacturer Narrative
Device evaluation: no product was returned for evaluation.One photo with no known lot number was sent for assessment.The image received depicts an intubation tube, the photo centers on the cuff¿s seal.The complaint description mentions a gas leakage on the seal between the cuff and tube body.No clear indication of a leakage can be identified on the image.No assessment can be made due to the low resolution and lack of detail on the photo.Leaking cannot be confirmed as no sample was returned for evaluation and no defect can be identified on the images sent.

• 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: 25067899
• Report Number: 3012307300-2026-04509
• Device Sequence Number: 10695341
• Product Code: BTR
• UDI-Device Identifier: 55019315022324
• UDI-Public: (01)55019315022324
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 100/199/070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown