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	100/199/080
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information has been provided to date.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 stated that the issue of the product is the leaking cuff.There was no reported patient involvement.
Additional Manufacturer Narrative
One device was returned for analysis.As received, no physical damage or other anomalies observed.The sample was leak tested using an air source.In order to facilitate leak detection, the sample was submerged underwater to detect air leakage.No leaks were observed from the cuff as tested.Unable to confirm the complaint of cuff leakage.

• 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 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24379971
• Report Number: 3012307300-2026-01428
• Device Sequence Number: 18714452
• Product Code: BTR
• UDI-Device Identifier: 15019315022340
• UDI-Public: (01)15019315022340(17)300723(10)6128636
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/14/2026

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: 100/199/080
• Device Lot Number: 6128636
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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