MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. Portex Tubes BLUselect Suctionaid; Tube, Tracheostomy (W/Wo Connector)

Catalog Number	101/860/080
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an air leak was observed from the cuff while the device was in use during an infusion at the healthcare facility.The event involved the patient; however, no patient harm or adverse effects were reported.
Additional Manufacturer Narrative
No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: Portex Tubes BLUselect Suctionaid
• Common Device Name: Tube, Tracheostomy (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: 50839679
• Report Number: 9617604-2026-00865
• Device Sequence Number: 10051286
• Product Code: BTO
• UDI-Device Identifier: 15019517077933
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 101/860/080
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• 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
• Patient Sex: Unknown