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

Catalog Number	67SN030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.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 balloon did not inflate.The event occurred during testing.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6: updated.H3: one device was received.Device was visually and functionally tested and the customer reported complaint was able to be confirmed.The cuff of the set was observed not to inflate.However, after following the ifu and gently massaging the cuff, the issue was resolved.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21678042
• Report Number: 3012307300-2025-03189
• Device Sequence Number: 15376978
• Product Code: JOH
• UDI-Device Identifier: 15021312000245
• UDI-Public: (01)15021312000245(17)260311(10)4122450
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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 Expiration Date: 03/11/2026
• Device Catalogue Number: 67SN030
• Device Lot Number: 4122450
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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