MAUDE Adverse Event Report: ICU MEDICAL 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	Break (1069)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
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 information becomes available.
Event or Problem Description
It was reported that the trach broke or was split while in use at the patient's home.Per reporter, medical intervention was required.Reporter alleged that the issue happened constantly and they have to wait for the following month to receive a replacement device.Reporter alleged that they are dealing with high mvi alarms on the patient's ventilator and lack of full oxygen supply due to this issue.
Additional Manufacturer Narrative
No product was returned, however two photos were returned for analysis.The photos were reviewed, and the reported issue was confirmed.The damage was located near the bond of the tube and the connector which caused the wire to be exposed.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23426635
• Report Number: 3012307300-2025-11940
• Device Sequence Number: 9798611
• Product Code: JOH
• UDI-Device Identifier: 10351688518699
• UDI-Public: (01)10351688518699
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 67PFSS40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 MO
• Patient Sex: Unknown
• Patient Weight: 8 KG