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

Model Number	BC192-05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in france reported that the tubing of a bc192-05 flexitrunk nasal tubing (subject device) was broken.The healthcare facility also reported that the patient experienced two oxygen desaturation events, with recorded oxygen saturation levels of 62% and 54% spo2, prior to the replacement of the subject device to continue therapy.No further patient consequences were reported.Fisher & paykel healthcare (f&p) has requested additional information from the healthcare facility regarding the reported event.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
(b)(4).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, bc192-05 flexitrunk nasal tubing was returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is thus based on the evaluation of the returned device, information provided by the healthcare facility, and our knowledge of the product.Results: visual inspection of the subject device confirmed that the tubing was torn and stretched on the film at the circuit connector side.The film was observed to be wrinkled and torn.Conclusion: based on the evaluation of the returned device, the information provided by the healthcare facility, and our knowledge of the product, the reported event could have resulted from the device being subjected to excessive force.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.To remind the user to take extra care when handling the flexitrunk nasal tubing, a caution insert is included in the packaging of each flexitrunk.Additionally, the user instructions which accompany the 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".
Event or Problem Description
A healthcare facility in france reported that the tubing of a bc192-05 flexitrunk nasal tubing (subject device) was found to be broken.The healthcare facility also reported that the patient experienced two episodes of oxygen desaturation lasting less than a minute, with recorded oxygen saturation levels of 62% spo2 and 54% spo2.While the subject device was being replaced to continue therapy, it was reported that the patient received manual ventilation and supplemental oxygen delivered under the nose.No further patient consequences were reported upon replacement of the subject device.

• Brand Name: F&P FLEXITRUNK
• 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: 24310812
• Report Number: 9611451-2026-00523
• Device Sequence Number: 5650058
• Product Code: BZO
• UDI-Device Identifier: 09420012413406
• UDI-Public: (01)09420012413406(10)2103809566(11)250610(17)280610
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: BC192-05
• Device Catalogue Number: BC192-05
• Device Lot Number: 2103809566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONTINUOUS MONITORING (CARDIORESPIRATORY MONITOR).; F&P RT265 BREATHING CIRCUIT.; FABIAN VENTILATOR.; TRANSCUTANEOUS PCO2 MONITORING.
• Patient Age: 1 MO
• Patient Sex: Unknown