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

Catalog Number	670180
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.E1 - initial reporter phone: (b)(6).H3: 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 on the first tracheostomy tube set, leakage was discovered after two days of usage.The reporter noted that on the second one, leakage was discovered after four days of usage.The old tracheostomy tube was replaced with a new one.There was unknown reported patient involvement.
Additional Manufacturer Narrative
H3 and h6 codes - updated.Two used devices were returned for investigation.The devices were visually inspected and no damage or anomalies were observed.Three pictures were returned.One showed the two sets and two showed leakages from the cuff of the set.During the functional testing, a leak was observed at the cuff of each set.Upon closer inspection a stretch like damage was observed at the location of the leak on both cuffs.The complaint of hole can be confirmed due to the damage observed on the cuffs.The probable cause of the damage is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: BIVONA ADULT TIGHT TO SHAFT SILICONE TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; 201 west queen street; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22285726
• Report Number: 3012307300-2025-07271
• Device Sequence Number: 8467759
• Product Code: JOH
• UDI-Device Identifier: 15021312006070
• UDI-Public: (01)15021312006070(17)290730(10)4462499
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: UNKNOWN
• 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): 04/07/2026

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: 4462499
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 04/07/2026
• 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
• Patient Sex: Unknown