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	100/199/075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a code blue, the patient had no heartbeat and cardiopulmonary resuscitation (cpr) and intubation were initiated.During an intubation attempt, the tracheal tube cuff inflation bulb reportedly burst, preventing cuff inflation and causing a delay of less than five minutes.Ventilation was maintained with a bvm/ambu bag between attempts.Return of spontaneous circulation (rosc) was not achieved, and the patient expired.The reporter stated that the death was not related to the device; however, patient harm was reported, while noting that it has not been established whether the harm was caused by our device.
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.

• 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; industrial int'l tijuana; tijuana NA 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50937144
• Report Number: 9617604-2026-01090
• Device Sequence Number: 10739689
• Product Code: BTR
• UDI-Device Identifier: 15019315022333
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: No
• Operator of Device: Other
• Device Catalogue Number: 100/199/075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Age: 69 YR
• Patient Sex: Female