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

Catalog Number	670180
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
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 information becomes available.
Event or Problem Description
It was reported that, when attempting to remove the tracheostomy tube after a month of use, cuff deflation was found to be difficult, with only 1 cc of water withdrawn.Per reporter, the tube was then slowly removed using a stylet while the cuff remained inflated.Subsequent testing confirmed that the cuff could not be deflated or inflated.The event occurred while in use with patient at the patient¿s home.No symptoms were reported.
Additional Manufacturer Narrative
D9 - date returned to mfg: 21-oct-2025.H3: one used sample, one image and one video were received for evaluation.Visual inspection was performed, and no damage or anomalies were observed.To replicate clinical use, the trach was filled with 10ml of water as per ifu using an icu medical provided syringe.The cuff inflated without difficulty.The cuff was then deflated without difficulty.The customer complaint of a broken cuff cannot be confirmed nor replicated.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA TUBES ADULT TIGHT TO SHAFT 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23011409
• Report Number: 3012307300-2025-10487
• Device Sequence Number: 10559607
• Product Code: JOH
• UDI-Device Identifier: 15021312006070
• UDI-Public: (01)15021312006070(17)290604(10)4462496
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083641
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 670180
• Device Lot Number: 4462496
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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
• Patient Sex: Unknown