MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUSELECT SUCTIONAID CUFFED TRACHEOSTOMY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/870/085
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died due to problems with the device.The balloon was deflating, and the patient was microaspirating, which contributed to the death.According to the caregiver, the patient aspirated multiple times, ultimately resulting in death by bronchoaspiration caused by a cannula obstructing the airway.
Additional Manufacturer Narrative
No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: PORTEX BLUSELECT SUCTIONAID CUFFED TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 75301 ; EZ 75301
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22554133
• Report Number: 3012307300-2025-08601
• Device Sequence Number: 18588149
• Product Code: BTO
• UDI-Device Identifier: 15019517076233
• UDI-Public: (01)15019517076233(17)290521(10)6012312
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: Lay User/Patient
• Device Model Number: 101/870/085
• Device Catalogue Number: 101/870/085CZ
• Device Lot Number: 6012312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• 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 Sex: Male