MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ENDOTRACHEAL TUBES MAXILLO FACIAL N/NASAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/133/070
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a surgical intubation performed using fibroscopy, once the intubation probe had been set up, it was found impossible to inflate the balloon.There was patient involvement.
Additional Manufacturer Narrative
One sample was returned for evaluation.Review of the lot history revealed no nonconformities that could have contributed to the reported complaint.Visual inspection of the device showed no damage or anomalies.Functional testing confirmed that the cuff inflated and deflated as expected; however, a cut was observed in the cuff of the set.The complainant¿s allegation was confirmed.The probable cause of the cut remains undetermined.

• Brand Name: PORTEX ENDOTRACHEAL TUBES MAXILLO FACIAL N/NASAL
• 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: 24926263
• Report Number: 3012307300-2026-03969
• Device Sequence Number: 21514767
• Product Code: BTR
• UDI-Device Identifier: 15019315020353
• UDI-Public: (01)15019315020353(17)301003(10)6144855
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: 100/133/070
• Device Lot Number: 6144855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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