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

Catalog Number	FT17JN35NGF033S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while preparing for trach change, the backup trach at bedside was not inflating symmetrically.New tube obtained and this tube inflated symmetrically.Event occurred at the hospital and the operator of the device was a health professional.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.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
One used sample was received for evaluation for the complaint that while preparing for trach change, the backup trach at bedside was not inflating symmetrically.The device history review could not be performed as the given lot number was unknown.The visual inspection of the returned device by the unaided eye and under normal plant lighting did not identify any defects.The device was leak tested and no leaks were identified.The investigation determined that the cuff symmetry met the manufacturing specification.

• Brand Name: BIVONA CUSTOM TTS FLEXTEND 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 ; 5700 w 23rd ave; gary, IN 46406 ; 2247062300
• MDR Report Key: 21707810
• Report Number: 1824231-2025-00017
• Device Sequence Number: 4656767
• Product Code: JOH
• UDI-Device Identifier: 15019517126952
• UDI-Public: (01)15019517126952
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: FT17JN35NGF033S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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