MAUDE Adverse Event Report: ICU MEDICAL, INC. BIVONA FLEXTEND PLUS PEDIATRIC AND NEONATAL TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFPS60
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that foam gauze from under trach tie and trach flange broke.The event occurred while in use with patient, and it happened in bed.Operator of the device was the nurse.The issue was resolved by changing the trach tube to new one.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Device evaluation: one device received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint was confirmed.It was found that the eyelet of the flange was torn.The deformation of the tear was uneven.The root cause could not be determined.

• Brand Name: BIVONA FLEXTEND PLUS PEDIATRIC AND NEONATAL TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; 201 west queen street; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22571820
• Report Number: 3012307300-2025-08770
• Device Sequence Number: 9700504
• Product Code: JOH
• UDI-Device Identifier: 10351688518583
• UDI-Public: (01)10351688518583(17)300402(10)6099896
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 67PFPS60
• Device Lot Number: 6099896
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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 Age: 20 YR
• Patient Sex: Male
• Patient Weight: 88 KG