MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA ADULT TTS SILICONE CUFFED TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670170
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that cuff leakage was found after using the trach on the patient for about 2 weeks.The problem was resolved when a new trach tube was placed.The event occurred while in use with patient at the hospital.This was reported to the fda.The operator of the device was a health professional.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
A1 - patient identifier was updated.D3 was updated.G4 - pma/510(k) # was updated.H3 and h6 were updated.One sample was returned for evaluation.Review of the lot history showed no nonconformities that could have contributed to the reported complaint.Visual inspection was performed, and a video provided by the complainant demonstrated a leak.Upon receipt, delamination-like damage was observed on the shaft of the trach, particularly around the inflation line.Functional testing confirmed a leak originating from the previously noted damage.The complainant¿s allegation was verified; however, the probable cause of the issue could not be determined.

• Brand Name: BIVONA ADULT TTS SILICONE CUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4, parque; industrial internacional; tijuana IN 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21573134
• Report Number: 3012307300-2025-02675
• Device Sequence Number: 8737555
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: (01)15021312006056(17)290530(10)4462476
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083641
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: 4462476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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