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

Catalog Number	100/133/060
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
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 the tracheal tube cuff deflated immediately upon re-intubation, following a similar failure and requiring the patient a total of four times, three more times following this incident.According to the reporter, during a stomatological procedure, a size 6.0 tracheal tube was used for left nasal intubation via the left nostril with the assistance of a video laryngoscope.Passage through the nasal turbinates was achieved without difficulty.Intubation was described as easy, with good visualization of the vocal cords, and magill forceps were not utilized.The reporter stated that during attempted cuff inflation, inflation failure was observed, as the cuff progressively deflated during inflation.Per the anesthesiologist, no issue was identified with the cuff valve.The initial tube was replaced with a second tube of the same type and size; however, the same cuff deflation issue was observed.A third tube change was then performed using a reinforced (armored) size 5.5 tube.Intubation was successful; however, the cuff deflation issue persisted.A fourth tube, a reinforced tube obtained from the equipment reserve, was subsequently used, and the reported issue did not recur.
Additional Manufacturer Narrative
D3 - postal code was updated.D7a - single use device was updated.The suspected device was not received for evaluation.The device history file was reviewed.There were no nonconformities were identified that may have contributed to the reported complaint.The complaint cannot be replicated or confirmed, and a root cause was unable to be determined.A good faith effort was conducted to retrieve the device from the customer.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL 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: 24965603
• Report Number: 3012307300-2026-04112
• Device Sequence Number: 13386074
• Product Code: BTR
• UDI-Device Identifier: 15019315020339
• UDI-Public: (01)15019315020339(17)280724(10)4414912
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: 100/133/060
• Device Lot Number: 4414912
• Was Device Available for Evaluation?: No
• 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: 05/22/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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
• Patient Sex: Unknown