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	67PFSS55
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that the cuff was not inflating properly, unevenly.The product fault occurred while in use with a patient.There was medical intervention when the patient experienced discomfort.The trach was removed and exchanged for a different brand.Outcome of the event was resolved with alternative trach.
Additional Manufacturer Narrative
H3: device not returned to manufacturer.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 updated device evaluation: no product was returned.Based on the review of information provided from the customer and no device was returned for review, a product evaluation cannot be performed to confirm the reported problem.If the product is returned at a later date, the complaint will be reopened and an investigation will be completed.
Additional Manufacturer Narrative
D9.Date returned to mfg: 13-dec-2024.H6.Investigation codes: updated.Investigation summary: received two (2) used list# 67pfss55 pediatric tracheostomy tube.As received no damage or anomalies were observed.A syringe was attached to the pilot balloon of each tube and slowly inflated with 5ml of sterile water per packaging directions.The cuff of the set was observed inflate in each set.The complaint of cuff not inflating properly cannot be replicated or confirmed.A device history record could not be completed as no lot number was received.

• 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: 20736713
• Report Number: 9617604-2024-00885
• Device Sequence Number: 8614286
• Product Code: JOH
• UDI-Device Identifier: 10351688518729
• UDI-Public: (01)10351688518729
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2025

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: Other
• Device Catalogue Number: 67PFSS55
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/11/2024; 03/12/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/06/2025; 04/04/2025
• 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: 12 YR
• Patient Sex: Unknown
• Patient Weight: 32 KG
• Patient Race: White