MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA NEONATAL TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67NFPS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the outside balloon inflates, inner cannula balloon internal to patient does not.Balloon was checked prior to first use.There was no patient involvement, and no patient harm/adverse event reported.
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 reportable information becomes available.
Additional Manufacturer Narrative
No device was received for investigation.Therefore, we are unable to determine the reported complaint.If we receive the device, we will reopen the investigation for further evaluations.
Additional Manufacturer Narrative
One used device was received for evaluation.Functional and visual testing were performed; however, the reported issue could not be duplicated.No damage or anomalies were observed in the as-received condition.A syringe was attached to the pilot balloon of the tube and slowly inflated with 5ml of sterile water per packaging directions.The cuff did not inflate.The cuff was gently squeezed and massaged and the cuff inflated.The complaint of the cannula would not inflate can be confirmed.Probable cause is unknown.

• Brand Name: BIVONA NEONATAL TRACHEOSTOMY TUBE
• 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 n; minneapolis, MN 60045 ; 2247062300
• MDR Report Key: 20386331
• Report Number: 9617604-2024-00779
• Device Sequence Number: 20849583
• Product Code: JOH
• UDI-Device Identifier: 10351688518781
• UDI-Public: (01)10351688518781
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

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: 67NFPS30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 03/05/2026
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/19/2024; 03/26/2026
• 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