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

Catalog Number	67PFS35
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: received one (1) used list #67pfs35, pediatric tracheostomy tube 3.5 tts flextend v neck 1/ea; lot #4388120.Sample was received with documentation stating the used sample had already been decontaminated.As received, no damage or anomalies were observed.A video was returned showing a tracheostomy tube being inflated with a syringe.The cuff can be seen not fully inflating and the balloon holding a large portion of the injected water.A syringe was attached to the pilot balloon of the tube and slowly inflated with 5ml of sterile water per packaging directions.The cuff of the set was observed not to inflate completely, with a portion of the water remaining in the balloon.The cuff was gently massaged and the whole cuff inflated.The customer's issue could not be duplicated, and a root cause could not be determined.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
It was reported that upon installation of sterile water, the cuff port balloon hyperinflated before any fluid progressed through to inflate the cuff.Over inflated cuff port balloon does not indicate inflated cuff, therefore the external mechanism for cuff inflation assessment is inaccurate.There was unknown patient involvement and unknown patient harm/adverse event reported.

• Brand Name: BIVONA TTS PEDIATRIC FLEXTEND V NECK 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: 21596365
• Report Number: 3012307300-2025-02819
• Device Sequence Number: 15520360
• Product Code: JOH
• UDI-Device Identifier: 10351688518613
• UDI-Public: (01)10351688518613(17)280325(10)4388120
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K923878
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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: 67PFS35
• Device Lot Number: 4388120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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