MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD F&P FLEXITRUNK; NASAL TUBING

Model Number	BC191-05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Section g4: no 510(k) number was included due to the subject device being exempt from pma pathway to regulatory approval.Fisher and paykel healthcare (f&p) is currently in the process of obtaining further information regarding the reported event.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor in brazil reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the tubing of an bc191-05 flexitrunk nasal tubing was found to be broken, resulting in an air leak.There was no reported patient involvement.

• Brand Name: F&P FLEXITRUNK
• Common Device Name: NASAL TUBING
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 24528643
• Report Number: 9611451-2026-00819
• Device Sequence Number: 9746605
• Product Code: BZO
• UDI-Device Identifier: 09420012413635
• UDI-Public: (01)09420012413635(10)2103759142(11)250508(17)280508
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: Health Professional
• Device Model Number: BC191-05
• Device Catalogue Number: BC191-05
• Device Lot Number: 2103759142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 05/10/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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 Sex: Unknown