MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670170
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that leakage was identified on the third day of use while the device was in use with a patient.The issue was resolved by replacing the device with another brand.The event occurred in a hospital and was handled by a health professional.The outcome was resolved.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation and photos provided by the customer.As received, there were no damages or anomalies observed.In order to replicate clinical use, the trach was filled with 5ml of water using an icu medical provided syringe as per ifu.A pinhole leak from the trach cuff was observed immediately after filling.Visual and functional testing was performed.The complaint of leakage can be confirmed.The probable cause of the reported problem unknown.
Additional Manufacturer Narrative
D4 - primary udi number: corrected.D4 - lot #, h3, h6: updated.The suspect product was returned for evaluation.Visual inspection confirmed that there were no anomalies found.The lot history review was performed, and it was confirmed that there were no previous conformities noted.Functional test was performed and it was found that there was a pinhole leakage from the trach cuff.The allegation made by the complainant was confirmed.However, the probable root cause of the event was unable to be determined.

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25015556
• Report Number: 3012307300-2026-04273
• Device Sequence Number: 9655295
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: (01)15021312006056
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2026

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: 670170
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 06/15/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/10/2026; 07/03/2026
• 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