MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67NFPS30
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the trach placed.Unable to pass suction catheter.Ent scoped and noted obstruction inside trach tube.There was patient involvement and there was no patient harm.Event occurred during immediate on use at the hospital, and it was operated by a health professional.The patient initial is sh, a female.She 3-month-old, 5.52 kg.She was a non-hispanic/latino, and a white.
Additional Manufacturer Narrative
One used neonatal tracheostomy tube was received for evaluation.As received, a partial occlusion was observed on the inner diameter of the shaft.In attempts to better visualize the partial occlusion the tube was cut open.The occlusion was confirmed to be attached to the shaft itself and appears to be parent material.The reported issue was confirmed.The probable cause is due to an errant solvent error during manufacturing in tijuana.The lot history was reviewed, and no relevant nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL 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: 23661449
• Report Number: 3012307300-2025-12940
• Device Sequence Number: 10375156
• Product Code: JOH
• UDI-Device Identifier: 10351688518781
• UDI-Public: (01)10351688518781(11)290210
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 67NFPS30
• Device Lot Number: 4459573
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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 Age: 3 MO
• Patient Sex: Female
• Patient Weight: 5 KG