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

Model Number	BC3520-10
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Section d4: lot number, expiration date, udi details are not provided by the customer.Section g4: pma/510(k) number: no 510(k) number was added in section g4 of the report because the device is a class 1 device and exempt from pma pathway to regulatory approval.Section h4: manufacturing date was not provided by the customer.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 (b)(6) has reported via a fisher & paykel healthcare (f&p) representative that the two units of bc801-10 infant nasal mask medium bcpap could not hold a seal and leaks.There was no reported patient consequence as the masks were replaced immediately after noticing the reported failure.
Event or Problem Description
A healthcare facility in new york has reported via a fisher & paykel healthcare (f&p) representative that the two units of bc3520-10 infant nasal prongs could not hold a seal and leaks.There was no reported patient consequence as the prongs were replaced immediately after noticing the reported failure.
Additional Manufacturer Narrative
(b)(4) additional information: section b5, d4, h4: during investigation, it was identified that the reported devices are of bcpap nasal prongs.Updated the sections with nasal prongs information.Section g4: pma/510(k) number - no 510(k) number included due to the subject device being exempt from pms pathway to regulatory approval.Method: the subject devices, bc3520-10 infant nasal prongs were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photography provided by the healthcare facility and our knowledge of our product.Results: the healthcare facility reported that the subject prongs could not hold a seal and leak.Visual inspection of the provided photography could not determine or confirm the reported failure.Conclusion: without the subject device being returned for evaluation, we are unable to determine the exact cause of the reported fault.The user instructions that accompany the flexitrunk infant interface illustrate in pictorial format the correct set-up and proper use of infant interfaces, including the nasal prong and nasal tubing.It also states the following: "connect prongs and mask to nasal tubing ensuring that it is inserted fully." "check that all circuit connections are tight before use and after any adjustment.".

• Brand Name: FISHER AND PAYKEL HEALTHCARE
• Common Device Name: NASAL PRONG
• 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: 21781271
• Report Number: 9611451-2025-00297
• Device Sequence Number: 7844672
• Product Code: BZO
• UDI-Device Identifier: 09420012432551
• UDI-Public: (01)09420012432551(10)2103550090(11)241227(17)271227
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Model Number: BC3520-10
• Device Catalogue Number: BC3520-10
• Device Lot Number: 2103550090
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/05/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2024
• 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