MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TIGHT TO SHAFT PEDIATRIC V-NECK FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67P040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2025-00189-00.The date of that submission was 17-mar-2025.H3: one sample was received.Sample was visually and functionally tested and the customer reported complaint was unable to be confirmed.It was identified that a portion of the cuff remained adhered to the tube.However, following the instructions for use, the cuff was massaged and fully inflated as expected.A retrospective review of 12-month period was made for complaints originated related to this issue and one additional complaint ((b)(4), not confirmed) was identified to this part number and lot for the "will not inflate¿ failure and no additional complaints were identified for the "pilot balloon issue¿ failure.
Event or Problem Description
It was reported that the balloon could not seem to be inflated completely.There were unknown patient harm or adverse effects reported as a result of the event.

• Brand Name: BIVONA TIGHT TO SHAFT PEDIATRIC V-NECK FLANGE 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22005940
• Report Number: 3012307300-2025-05541
• Device Sequence Number: 7266662
• Product Code: JOH
• UDI-Device Identifier: 15021312006278
• UDI-Public: (01)15021312006278(17)290704(10)6017532
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/12/2025

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: 67P040
• Device Lot Number: 6017532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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