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 Codes	Gas/Air Leak (2946); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cuff leakage was found after 10 days of use.The problem was resolved by replacing the trach tube with a new one.The event occurred while in use with the patient at the hospital.The device was operated by the user/patient.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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
D9: 6/4/2025.One (1) used device was received for evaluation.A visual inspection was performed, and the reported issue could be duplicated.Upon further inspection under magnification, multiple small tears were observed on the cuff of the trach.In order to replicate clinical use, the trach was filled with 10ml of water as per ifu using an icu medical provided syringe.The cuff failed to inflate and a leak was observed immediately after filling.The probable cause is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• 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.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22018882
• Report Number: 3012307300-2025-05684
• Device Sequence Number: 9412287
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: Lay User/Patient
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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