MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TUBES ADULT AIRE-CUF; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	750180
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tracheotomy balloon did not remain inflated and had significant leaks.There was a patient involvement.Patient impact: ventilatory difficulty.
Additional Manufacturer Narrative
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 information becomes available.
Additional Manufacturer Narrative
One used trach tube was returned for analysis of complaint that the tracheotomy balloon did not remain inflated and had significant leaks.As received, there were no damages or anomalies observed.In order to replicate clinical use, the trach cuff was inflated with 10ml of air.The cuff did not retain any of the filled air.The cuff was checked for leaks by submerging it in water.A leak was observed from the cuff.Upon closer inspection under magnification, micro tears were observed on the cuff surface.The damage on the cuff is consistent with damage observed with contact with teeth during insertion.The complaint of cuff deflation/leakage can be confirmed.The probable cause is due to a molding error during manufacture.A lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: BIVONA TUBES ADULT AIRE-CUF
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22903351
• Report Number: 3012307300-2025-10073
• Device Sequence Number: 15666352
• Product Code: JOH
• UDI-Device Identifier: 15021312006421
• UDI-Public: (01)15021312006421
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: Lay User/Patient
• Device Catalogue Number: 750180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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 Age: 70 YR
• Patient Sex: Male