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

Model Number	BC191-05
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in china on behalf of a healthcare facility reported via fisher and paykel healthcare (f&p) field representative that the tubing of a bc191-05 flexitrunk nasal tubing 70mm was broken.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Section g4: no 510(k) number was included due to the subject device being exempt from pma pathway to regulatory approval.Fisher & paykel healthcare (f&p) is in the process of completing our investigation.We will provide a follow-up report upon completion of our investigation.
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.Method: the subject device, bc191-05 flexitrunk nasal tubing was not returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is based on the evaluation of the information and photography provided by the healthcare facility, and our knowledge of the product.Results: evaluation of the provided photography revealed that one of the tubes was torn and stretched at the circuit connector end.The film was observed to be wrinkled and torn.Conclusion: based on evaluation of the returned device, information and photography provided by the healthcare facility, and our knowledge of the product, it is most likely that the reported event resulted from the device being subjected to excessive force.It appears that the tubes have been pulled to an unintended extension 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 flexi trunk nasal tubing 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." additionally, a caution insert is included in the packaging to remind the user to take extra care when handling the flexitrunk nasal tubing.
Event or Problem Description
A distributor in china on behalf of a healthcare facility reported that the tubing of a bc191-05 flexitrunk nasal tubing 70mm was broken.There was no reported patient involvement.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• 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: 23600767
• Report Number: 9611451-2025-01493
• Device Sequence Number: 18456196
• Product Code: BZO
• UDI-Device Identifier: 09420012413635
• UDI-Public: (01)09420012413635(10)2103531652(11)241212(17)271212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: Other
• Device Model Number: BC191-05
• Device Catalogue Number: BC191-05
• Device Lot Number: 2103531652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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