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	100/199/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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 the device was leaking.The cuff was checked pre-anesthesia and was intact and holding pressure.Intubation was performed without complication using direct laryngoscopy.During the procedure, a cuff leak occurred intraoperatively (once approximately 2 hours into the operation and once just prior to emergence).Inspection identified leakage at the junction where the cuff is bonded to the tracheal tube.Additional cuff inflation was attempted but the cuff would not maintain pressure.The patient was extubated and ventilated via mask with a two-hand technique and oropharyngeal airway.Re-intubation was attempted using a video laryngoscope (d-blade) with multiple stylet attempts.The patient was ventilated between attempts and maintained oxygen saturation of 99%.Tube placement was confirmed by etco2 and auscultation, secured, and the procedure continued without further issue.Subsequent examination of the original tube confirmed a significant leak at the upper cuff attachment site.There was patient involvement, but no patient injury was reported.
Additional Manufacturer Narrative
D9 - date returned to mfg: 2/17/2026.H3 and h6 codes - updated.One used device was returned for investigation.The device was visually inspected and there were no damages or anomalies observed.One (1) customer photo and one (1) video were returned showing cuff leakage at the proximal weld.During the functional testing, the trach tube was then submerged underwater to facilitate leak detection.Initially, there was no leakage observed.After five minutes of the cuff remaining inflated, the cuff weld channel grew until a leak occurred.The leak originated from the trach tube cuff weld (proximal).The complaint of leakage can be confirmed.The probable cause is due to a cuff welding error during manufacturing.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• 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 ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24401031
• Report Number: 3012307300-2026-01531
• Device Sequence Number: 8168257
• Product Code: BTR
• UDI-Device Identifier: 55019315022324
• UDI-Public: (01)55019315022324
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 100/199/070
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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