MAUDE Adverse Event Report: ICU MEDICAL, INC. BIVONA TTS FLEXTEND TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT22BN35NGE072N
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	10/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was stated that while in use with patient the vent alarmed a leak, and it was observed that there was a tear by the shaft and flange.The event happened at patient's home, but the operator of the device was a healthcare provider.The issue was resolved after they changed the trach to a backup.No medical intervention was required.Patient was an 18-month white, non-hispanic male baby.The weight of the patient is 19 lbs.The device is available for investigation.There was patient involvement, but no patient harm/adverse event reported.
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.Device has not been returned to the manufacturer.
Additional Manufacturer Narrative
D9: date returned to mfg; 11/12/2024.D3: mfg establishment name; icu medical, inc.Device evaluation: one used device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint could be confirmed but cannot be attributed to the manufacturing process.It was seen that the damage was caused from excessive movement, which caused the wire structure to wear on the silicone rubbing through.

• Brand Name: BIVONA TTS FLEXTEND TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20683497
• Report Number: 1824231-2024-00097
• Device Sequence Number: 7229885
• Product Code: JOH
• UDI-Device Identifier: 15019517295429
• UDI-Public: (01)15019517295429(17)290507(10)GB020682
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: FT22BN35NGE072N
• Device Lot Number: GB020682
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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 Age: 18 MO
• Patient Sex: Male
• Patient Weight: 9 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White