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

Catalog Number	67NFP40
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/25/2025
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 information becomes available.
Event or Problem Description
It was reported that a trach was dislodged during patient transfer from bed to scale.Following code event, the nurse inspected trach and noted that the cuff had 1.5ml of water and the trach did not inflate.The nurse then filled it at its maximum capacity of 3ml, thus trach still did not inflate all the way around.After the patient was stabilized, they tried to use an additional product to resolve the issue but to no avail.There was patient involvement and outcome of the injury is still ongoing.Cpr(cardiopulmonary resuscitation) and increased patient care needed are listed as medical intervention.
Additional Manufacturer Narrative
D9: 8/26/2025.One used sample was received for evaluation.Visual and functional testing were unable to verify or duplicate the reported problem.A probable root cause was unable to be established.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22798346
• Report Number: 3012307300-2025-09674
• Device Sequence Number: 8286760
• Product Code: JOH
• UDI-Device Identifier: 10351688518767
• UDI-Public: (01)10351688518767
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: 67NFP40
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/20/2025
• 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: 11 MO
• Patient Sex: Female
• Patient Weight: 8 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White