MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX ENDOTRACHEAL TUBES MAXILLO FACIAL N/NASAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/133/070
Medical Device Problem Codes	Mechanical Problem (1384); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device exhibited a leakage cuff post intubation nasally.The patient was extubated and intubated nasally with second nasal tube, however slow loss of cuff pressure was noted.The patient was successfully re-intubated with reinforced nasally with no issues.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Two used devices were received for evaluation.As received, there were no damages or anomalies observed.Functional testing was performed and, a leak was observed at the cuff surface.The damage on the cuff is consistent with damage observed with contact with teeth during insertion.The complaint of cuff deflation/leakage was confirmed.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PORTEX ENDOTRACHEAL TUBES MAXILLO FACIAL N/NASAL
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22509320
• Report Number: 3012307300-2025-08367
• Device Sequence Number: 13112305
• Product Code: BTR
• UDI-Device Identifier: 15019315020353
• UDI-Public: (01)15019315020353(17)281208(10)4447001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K931735
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 100/133/070
• Device Lot Number: 4447001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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