MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/199/070
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned to manufacturer.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 information becomes available.
Event or Problem Description
It was reported that the balloon of the portex tracheal tube deflated slowly during patient use.There was patient involvement, and no patient harm/ adverse event reported.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection was performed.The complaint of the balloon deflating slowly can be confirmed.The probable cause is the pilot ballon coming in contact with a sharp object that created the hole in the pilot balloon.A device history record 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, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24344426
• Report Number: 3012307300-2026-01272
• Device Sequence Number: 15808283
• Product Code: BTR
• UDI-Device Identifier: 55019315022324
• UDI-Public: (01)55019315022324(17)300703(10)6121802
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: UNKNOWN
• 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,Followup
• Report Date (Section B): 04/23/2026

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
• Device Lot Number: 6121802
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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