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

Catalog Number	67P050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the cuffed tube failed to inflate.The event was discovered during post tube insertion in the hospital with patient involvement.They had to remove the tube and insert a new one.The event was resolved with the new tube insertion.The cuff was inflated with 4 mls water for injection.When the tube was replaced with a working tube with the same size and style tracheostomy the 4 ml cuff inflation allowed the internal cuff to inflate.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.One device sample was received in used condition, in a plastic bag.During visual inspection no damage or other defects were detected on the sample.An inflation test was performed, and at the beginning of the test the cuff failed to inflate, but according to the instructions for use the cuff was massaged and inflated without problems.Based on the analysis performed on the sample provided and the reported by the customer, no root cause could be determined since the complaint was not confirmed due sample provided does not shows the failure mode reported, no failure identified.The failure mode will continue to be monitored and if a trend is identified the issue will be escalated.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA TTS PEDI V NECK FLANGE
• 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: 19299145
• Report Number: 9617604-2024-00421
• Device Sequence Number: 5855537
• Product Code: JOH
• UDI-Device Identifier: 15021312006292
• UDI-Public: (01)15021312006292(17)250921(10)4053732
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/21/2024

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 Expiration Date: 09/21/2025
• Device Catalogue Number: 67P050
• Device Lot Number: 4053732
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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 YR
• Patient Sex: Male