MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	101/563/090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.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.
Event or Problem Description
It was reported that the above-cuff suction aid blue port was cracked, and the tracheostomy was successfully changed.No adverse patient effects were reported.
Additional Manufacturer Narrative
One used device was received from lot number 4446567.Visual inspection was performed, and the reported issue was confirmed.It was identified that the suction connector was cracked.Root cause of this defect is currently unknown - it could be a molding defect or excessive force used when connector was connected with syringe during use.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.One other customer complaint was received against the affected lot number which is describing the same issue and was confirmed.

• Brand Name: BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 22883951
• Report Number: 3012307300-2025-09958
• Device Sequence Number: 9604749
• Product Code: JOH
• UDI-Device Identifier: 15019517103427
• UDI-Public: (01)15019517103427(17)270110(10)4446567
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173912
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 101/563/090
• Device Lot Number: 4446567
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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