MAUDE Adverse Event Report: FISHER & PAYKEL HEATHCARE LTD FISHER & PAYKEL HEALTHCARE; NASAL TUBING

Model Number	BC191-05
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that the tubing of a bc191-05 flexitrunk nasal tubing was torn and resulted in a leak during use.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(6).Section g4: no 510(k) number was included in section g4 of the report because the device is exempted from pma pathway to regulatory approval.Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that the tubing of a bc191-05 flexitrunk nasal tubing was torn and resulted in a leak during use.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(6).Section g4: no 510(k) number was included in section g4 of the report because the device is exempted from pma pathway to regulatory approval.Method: the subject device, bc191-05 flexitrunk nasal tubing was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the healthcare facility, and our knowledge of the product.Results: the healthcare facility reported that the tubing of a bc191-05 flexitrunk nasal tubing was torn and resulted in a leak during use conclusion: we are unable to determine the cause of the reported event.All flexitrunk infant nasal tubing's are visually inspected, and pressure tested during production and those that fail are rejected.This suggests that the damage on the subject nasal tubing occurred after it was released for distribution.Our user instructions which accompany the bc190 bubble cpap system state: - "always use pressure monitoring to verify that the patient is receiving the prescribed cpap level." - "handle with care.Use caution when positioning or disconnecting the interface.Avoid excessive pull forces, sharp objects, and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement." - "use patient oxygen monitoring".Additionally, a caution insert is included in the packaging to remind the user to take extra care when handling the bc191-05 flexitrunk nasal tubing.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: NASAL TUBING
• Manufacturer (Section D): FISHER & PAYKEL HEATHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEATHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego vargus banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 23835437
• Report Number: 9611451-2025-02057
• Device Sequence Number: 9267655
• Product Code: BZO
• UDI-Device Identifier: 09420012413635
• UDI-Public: (01)09420012413635(10)2103822234(11)250618(17)280618
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 2103822234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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