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

Catalog Number	67PFSS40
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the bivona tracheostomy cuff did not inflate.There was unknown patient harm or adverse events being reported as a result of the event.
Additional Manufacturer Narrative
One sample was received for evaluation.The cuff of the set was observed not to inflate; all the fluid was retained in the pilot balloon.The set was gently massaged per ifu and the cuff was observed to inflate.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Additional Manufacturer Narrative
One opened and unused device was returned for evaluation.As received, no damage or anomalies were observed.Functional testing was performed and the cuff of the set was observed not to inflate, and all the fluid was retained in the pilot balloon.The set was gently massaged per ifu and the cuff was observed to inflate.The complaint of product not inflating can be confirmed.However, after massaging the cuff the issue was resolved.The ifu states: "if the cuff does not inflate completely, squeeze the pilot balloon while gently manipulating the cuff from the shaft." the lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
Additional information was received that the product fault occurrence was when they took it out from the box.There was no patient involvement.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21777061
• Report Number: 3012307300-2025-03788
• Device Sequence Number: 8000607
• Product Code: JOH
• UDI-Device Identifier: 10351688518699
• UDI-Public: (01)10351688518699(17)290226(10)4469919
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 67PFSS40
• Device Lot Number: 4469919
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 06/09/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/30/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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