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

Model Number	BC191-05
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)(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 infant nasal tubing was not returned to fisher & paykel healthcare (f&p).Our investigation is thus based on the photography and information provided by the healthcare facility and our knowledge of the product.Results: evaluation of the provided photos confirmed that the subject device was leaking between the tubing and the connector.No damage to the tubing or the connector was observed.Conclusion: without the return of the subject device for evaluation, we are unable to determine the cause of the reported event.As part of the manufacturing process, each flexitrunk infant nasal tubing device undergoes visual inspection and leak testing.Devices that do not meet the specifications are rejected and not released for distribution.The user instructions which accompany the bc192-05 flexitrunk nasal tubing include the following: "handle with care.Use caution when positioning or disconnecting to the infant interface.Avoid excessive pull forces, sharp objects, and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement." "disconnect the flexitrunk interface gently by twisting the connectors.Do not pull forcefully, as this may damage the tubing.Handle with care" "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.
Event or Problem Description
A healthcare facility in west virginia has reported via a fisher & paykel healthcare (f&p) field representative that the a bc191-05 flexitrunk nasal tubing was found leaking at the connector.There were no reported patient consequences.

• 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: 24750338
• Report Number: 9611451-2026-01068
• Device Sequence Number: 10071410
• Product Code: BZO
• UDI-Device Identifier: 09420012413635
• UDI-Public: (01)09420012413635(10)2103785210(11)250523(17)280523
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 04/01/2026

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: 2103785210
• 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: 03/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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