MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA ADULT TIGHT TO SHAFT SILICONE TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670180
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the leakage was found after 9 days of use.This problem was resolved by replacing a new air-cuff.The event occurred while in use with patient at the hospital.
Additional Manufacturer Narrative
E1: (b)(6).H3: 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 information becomes available.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during visual inspection and functional testing when the reported leakage from the device cuff was verified.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.The investigation could not determine a root cause for the observed tear in the device cuff.

• Brand Name: BIVONA ADULT TIGHT TO SHAFT SILICONE TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; avenida calidad no.4; parque industrial intl; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22048301
• Report Number: 3012307300-2025-05815
• Device Sequence Number: 13081421
• Product Code: JOH
• UDI-Device Identifier: 15021312006070
• UDI-Public: (01)15021312006070(17)290604(10)4462495
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: UNKNOWN
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: Health Professional
• Device Catalogue Number: 670180
• Device Lot Number: 4462495
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 07/19/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2024
• 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: Required Intervention
• Patient Sex: Unknown