MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TTS ADJUSTABLE HYPERFLEX TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67HA80
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the second day of the patient's treatment, the locking pin came loose from the tube.A new tracheostomy tube was used to fix the issue.The incident occurred while the patient was being treated.The event occurred in the hospital and was operated by health professional.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
The review of the return product showed the pin was removed from the locking strap.There are signs the pin was seated at one time.The pin was reseated by following wi-09-0310-24 section 8.11.The pin went in and locked the locking strap and tried to forcibly pull the pin out but could not remove the pin.The gary site no longer manufactures the adult adjustable product, the process has moved to tijuana, mexico and reached out to tijuana to get informed of this complaint.

• Brand Name: BIVONA TTS ADJUSTABLE HYPERFLEX TRACHEOSTOMY TUBE
• 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: 21573145
• Report Number: 3012307300-2025-02678
• Device Sequence Number: 18327411
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: (01)15021312013818(17)270407(10)4267588
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: 67HA80
• Device Lot Number: 4267588
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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