MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. Portex SACETT Suction Above Cuff Endotracheal Tube; Tube, Tracheal (W/Wo Connector)

Catalog Number	100/189/080
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury

• Brand Name: Portex SACETT Suction Above Cuff Endotracheal Tube
• 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: 50843035
• Report Number: 9617604-2026-00869
• Device Sequence Number: 10263626
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: UK
• PMA/510(K) Number: K081086
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 100/189/080
• Device Lot Number: Unknown
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• 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: Hospitalization
• Patient Age: 85 YR
• Patient Sex: Unknown