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

Catalog Number	60SP040
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a crack was found in the flange during use.There was no disinfection or sterilization, and no infectious disease occurred.There were no patient harms or adverse events reported as a result of the event.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2025-00147-00.The date of that submission was 18-feb-2025.B3: event date unknown.H3: one sample was received.During the visual inspection, it was identified that the flange component had a split near to the connector, on the side of the printed information.The customer reported complaint was confirmed.A dhr review was unable to be completed as no lot number was provided.

• Brand Name: BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
• 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: 22006493
• Report Number: 3012307300-2025-05546
• Device Sequence Number: 21107134
• Product Code: BTO
• UDI-Device Identifier: 15021312000382
• UDI-Public: (01)15021312000382
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2025

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: 60SP040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/12/2025
• 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