MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S BLUSELECT 8.0, SUCTIONAID, CUFFED; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/860/080CZ
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff could not inflate.There were no patient harm or adverse events reported.There was no disinfection or sterilization, and no infectious disease occurred.
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 complaint was incorrectly filed under this registration number.Reference mrn 3012307300-2025-03990-00 for details pertinent to this event.

• Brand Name: BLUSELECT 8.0, SUCTIONAID, CUFFED
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21510630
• Report Number: 3011237704-2025-00033
• Device Sequence Number: 8020759
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: (01)15019517076158(17)291028(10)6064208
• Combination Product (Y/N): N
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: 101/860/080CZ
• Device Lot Number: 6064208
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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 Sex: Unknown