MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE CUFFED, 9MM 1/CA*******EXTERNAL_; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/090CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device leaked when inflated.The date of the event was (b)(6) 2024 at 10:30.The event occurred during use on patient for less than 10 minutes.There was no patient harm reported.
Additional Manufacturer Narrative
E1 (b)(6).G4: 510k is unknown.No product information has been provided.Device has not been returned to date.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
One device was received for investigation in used condition with no visible signs of damage.Functional testing was completed where the cuff was inflated with air and submerged into a water bath.A leak was observed between the balloon and the inlet tube confirming the customer complaint.Root cause was not confirmed but the probable cause was attributed to a manufacturing issue.A review of the device history records show that there were no anomalies or non conformities during the manufacturing process.  one device was received for evaluation.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Due to this, no root cause was determined as the device worked as expected according to the instructions for use.Device history review of the reported lot number found no anomalies or discrepancies during the manufacturing process.
Event or Problem Description
It was reported that the device leaked when inflated.The date of the event was 20-jan-2024 at 10:30.The event occurred during use on patient for less than 10 minutes.There was no patient harm reported.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn: 3012307300-2025-05698 for details pertinent to this event.

• 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: 21366435
• Report Number: 3011237704-2025-00026
• Device Sequence Number: 8416560
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: (01)15019315107214(17)290715(10)6014868
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 100/897/090CZ
• Device Lot Number: 6014868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 01/21/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/02/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown