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	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 cannula was installed on 28-jul without problem.On 01-aug-2025: observation of bloating leak, balloon fragility at the introduction of the cannula in a percutaneous tracheotomy.Patient impact: desaturation.There was 1 patient involvement.No consequences for the current condition of the patient.Actions taken for the patient: change of device.
Additional Manufacturer Narrative
One used trach tube was received for analysis of deflation/leakage.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.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.The reported issue was cuff deflation/leakage can be confirmed.The probable cause is unknown.No damages or anomalies observed.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.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22893384
• Report Number: 3012307300-2025-10012
• Device Sequence Number: 20312367
• 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,Followup
• Report Date (Section B): 12/08/2025

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: Health Professional
• Device Catalogue Number: 750180
• Device Lot Number: UNKNOWN
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 11/20/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/08/2025
• 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: 71 YR
• Patient Sex: Male