MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/810/085CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 phone number: (b)(6).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that a leak in the device was noted during the balloon test.The cannula was still placed in the 68-year-old patient because the cannula initially in place had already been removed.A removal and a new installation took place.An identical reference device from an unknown batch was used as a replacement.No clinical consequences were observed.This incident led to the procedure being repeated twice.The date of event is 10-jan-2024.

• Brand Name: BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA
• 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: 21326474
• Report Number: 3011237704-2025-00019
• Device Sequence Number: 8696637
• Product Code: BTO
• UDI-Device Identifier: 15019517076318
• UDI-Public: (01)15019517076318(17)290624(10)6012313
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: Health Professional
• Device Catalogue Number: 101/810/085CZ
• Device Lot Number: 6012313
• 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: 01/27/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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
• Patient Age: 68 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG