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

Catalog Number	60SP035
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
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 there was a crack in the wing of the cannula.The event occurred while in use with patient and there was no human harm.
Additional Manufacturer Narrative
H6: evaluation codes update.One device was received for investigation.The device was visually inspected and functionally tested.During the visual inspection, it was identified that the flange component had a split near to the connector.The complaint is confirmed.Capa-0007682 was opened on 08/mar/2023 for bivona tracheostomy tube to address a full root cause investigation for damaged flange/neck strap issues, capa has been completed on 26/feb/2025.The probable cause is due to an error during manufacturing.

• Brand Name: BIVONA PEDIATRIC 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 22425
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20431185
• Report Number: 9617604-2024-00793
• Device Sequence Number: 12669345
• Product Code: JOH
• UDI-Device Identifier: 15021312000375
• UDI-Public: (01)15021312000375(17)280820(10)4414733
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 60SP035
• Device Lot Number: 4414733
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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