MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60SP045
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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 one month after use, the part where the flange's string passes through tore.The event occurred during use, and there was no reported patient harm/adverse event.
Additional Manufacturer Narrative
One pediatric tracheostomy tube was received for analysis.As received, partial tears were observed on the inner diameter of the eyelet at the flange.The damage was observed to be rough and uneven.Confirmed complaint that the part where the flange's string passes through was torn.The probable cause is unknown.The lot history was reviewed and no relevant nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 22977117
• Report Number: 3012307300-2025-10327
• Device Sequence Number: 9549146
• Product Code: BTO
• UDI-Device Identifier: 15021312000399
• UDI-Public: (01)15021312000399(17)291002(10)6059012
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 60SP045
• Device Lot Number: 6059012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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