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

Catalog Number	67PFSS40
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient brought with them to the clinic three broken trach tubes.Condition of use was straight out of the box, unused, with broken trach cuffs- slit where the cuff meets the shaft.The new trach removed from box, inflated cuff with sterile water with immediate leakage of water from cuff.The event occurred at patient's home.There were no patient harm or adverse event reported.
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.
Additional Manufacturer Narrative
H6: evaluation codes update.One device was received for investigation.The device was visually inspected and functionally tested.Leakage was observed on all three sets at the pilot balloon.Further inspection of the pilot balloons showed tears on the balloons.The root cause cannot be determined.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21283989
• Report Number: 3012307300-2025-01387
• Device Sequence Number: 20791068
• Product Code: JOH
• UDI-Device Identifier: 10351688518798
• UDI-Public: (01)10351688518798(17)241028(10)6058922
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 67PFSS40
• Device Lot Number: 6058922
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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