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

Catalog Number	60SP055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 flange on the tracheostomy tube broke.Therefore, the tracheostomy tube was not secured and was replaced.The duration of the implantation was 7 months.There was patient involvement, and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
H6: evaluation codes updated device evaluation: neither samples nor pictures were received for the analysis of this complaint.No device history record was reviewed since lot number was not provided.Complaint for the failure mode could not be confirmed by investigation as no samples nor pictures was provided by the customer.Without the return of the used samples a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.If the product is returned, lsm will reopen this complaint for further investigation.

• Brand Name: BIVONA PEDIATRIC UNCUFFED 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21036581
• Report Number: 9617604-2024-00958
• Device Sequence Number: 15588242
• Product Code: JOH
• UDI-Device Identifier: 15021312000436
• UDI-Public: (01)15021312000436
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60SP055
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Unknown