MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60PFSS30
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation included root cause, and 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 tracheostomy tube fractured at the connection site where the ventilator circuit attaches.This created a critical situation, as the break caused an immediate disconnection from the ventilator.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
D3: updated.D9 - date returned to mfr: 1-may-2026.H3 and h6 codes: updated.One (1) physical sample and two (2) photo samples were received.Lot history was reviewed, and no nonconformities were identified that could have contributed to the reported complaint.Visual inspection of the physical sample showed that the tube was split in half, exposing the internal wire, with the split exhibiting uneven edges.Two photographs were provided: the first displayed a tracheostomy tube with a significant split and exposed coil, while the second showed a smaller tear with coils also exposed.The complaint of breakage was confirmed.The probable cause of the damage could not be determined.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24910711
• Report Number: 3012307300-2026-03883
• Device Sequence Number: 9874691
• Product Code: JOH
• UDI-Device Identifier: 15021312516760
• UDI-Public: (01)15021312516760(17)300601(10)6115613
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: 60PFSS30
• Device Lot Number: 6115613
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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: 32 MO
• Patient Sex: Male
• Patient Weight: 4 KG
• Patient Race: White