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

Catalog Number	60NFP40
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that parent was planning a tube change when a small defect was noticed on the tube, at the end of the shaft.The defect was described as ¿a small circular shape, a hole, a bubble¿ within the shaft tubing.The remaining tubes were not used as alternatives.The fault was noticed by the parents before use, when box was opened.There was no patient involvement and no human harm/adverse event.
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.
Additional Manufacturer Narrative
H3: the device was received for evaluation.The device history review of the reported lot number found no non-conformities during the manufacturing process.Visual testing was performed, and a circular delamination anomaly was observed on the shaft of the tube below the flange.No additional damage or anomalies were observed.The probable cause of the issue was unknown.
Additional Manufacturer Narrative
H6: corrected.The investigation was updated with a probable cause for the defect found on the tube.The probable cause is due to a manufacturing error during the errant adhesive removal process.

• Brand Name: BIVONA FLEXTEND PLUS PEDIATRIC AND NEONATAL TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22473361
• Report Number: 3012307300-2025-08187
• Device Sequence Number: 12790462
• Product Code: JOH
• UDI-Device Identifier: 15021312014747
• UDI-Public: (01)15021312014747(17)290701(10)6026262
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2025

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: Lay User/Patient
• Device Catalogue Number: 60NFP40
• Device Lot Number: 6026262
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 08/29/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/18/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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