MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ENDOBRONCHIAL TUBES; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Catalog Number	198-37L---802
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the air was leaking from the cuff.The event occurred during priming at facility.
Additional Manufacturer Narrative
One used sample was received for evaluation.Visual and functional testing was unable to verify or duplicate the reported problem.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.
Additional Manufacturer Narrative
D4 - lot #, d4 - catalog #, d4 - primary udi number, d4 - expiration date, g4 - pma/510(k) #, and h4 - device mfg date: updated.

• Brand Name: PORTEX ENDOBRONCHIAL TUBES
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23609675
• Report Number: 3012307300-2025-12724
• Device Sequence Number: 9765620
• Product Code: CBI
• UDI-Device Identifier: 15019315058622
• UDI-Public: (01)15019315058622(17)271202(10)6075011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953483
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2026

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: 198-37L---802
• Device Lot Number: 6075011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 12/30/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/23/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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