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

Catalog Number	101/870/085CZ
Medical Device Problem Codes	Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
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
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 reportable information becomes available.
Additional Manufacturer Narrative
This supplemental report was generated to correct initial report emdr-71037.Sections b1, b2, b5, h1, and h6 have been updated.No patient harm or adverse event was reported.The investigation is awaiting return of the product.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported by a caregiver that the device balloon was not fixed, it was just fitted.There was patient involvement and no reported harm.
Additional Manufacturer Narrative
G1 - contact office zip code corrected; h4 - device mfg date corrected correction - as no device is available to be returned for evaluation.A device history record review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed.Due to fact that cuff leak was observed after placement it is probable that reported failure occurred during the tracheostomy procedure and contact with a sharp edge.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• 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 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22554974
• Report Number: 3012307300-2025-08622
• Device Sequence Number: 18567044
• Product Code: BTO
• UDI-Device Identifier: 15019517076233
• UDI-Public: (01)15019517076233(17)290701(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,Followup,Followup
• Report Date (Section B): 10/09/2025

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 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
• Supplement Date Received by Manufacturer: 06/27/2025; 10/09/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 07/22/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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: Unknown