MAUDE Adverse Event Report: ICU MEDICAL ASD, INC BIVONA CUSTOM 5.5 TTS FLEXTEND TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT24IN65NSC033N
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 patient's vent kept alarming during the night after 4ml of sterile saline was placed in the cuff earlier that day.The nurse performed standard care/interventions, but the vent continued to alarm intermittently through the night, so the nurse checked the trach cuff volume and found only 1.5ml.The cuff volume was increased back to 4ml.Within 45min the vent started to alarm again and there was only 2ml in the cuff when rechecked.Trach was changed to the new back-up trach with no issue.The cuff's inner piece that the syringe connected to came out and appeared to be where the leak may have been coming from.There was no delay of therapy.There was a medication used with this product.Only inhalers and nebulizers were used during routine scheduled airway clearance.Meds are also able to be used as needed when additional airway clearance is required.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
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 were performed during analysis.The customer reported complaint was confirmed, the cuff failed to retain pressure when filled with air.The probable cause of the defect is user error.

• Brand Name: BIVONA CUSTOM 5.5 TTS FLEXTEND TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU 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: 21067962
• Report Number: 1824231-2025-00001
• Device Sequence Number: 3279245
• Product Code: JOH
• UDI-Device Identifier: 10887709131245
• UDI-Public: (01)10887709131245(17)290910(10)GB026326
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: FT24IN65NSC033N
• Device Lot Number: GB026326
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INHALER ALBUTEROL; INHALER FLOVENT; SODIUM CHLORIDE 3%; SODIUM CHLORIDE 7%; SODIUM CHLORIDE 9%
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Unknown
• Patient Weight: 50 KG
• Patient Ethnicity: Hispanic
• Patient Race: White