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

Model Number	BC192-05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Method: the subject device, bc192-05 flexitrunk nasal tubing was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the evaluation of the information and photography provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the provided photography revealed that the tubing was torn near the end that connects to the breeathing circuit.Conclusion: we are unable to determine the cause of the reported event.However, 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.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 bc192-05 flexitrunk nasal tubing.
Event or Problem Description
A healthcare facility in australia reported that the tubing of a bc192-05 flexitrunk nasal tubing was broken when being removed from its packaging.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: 24466047
• Report Number: 9611451-2026-00624
• Device Sequence Number: 9360870
• Product Code: BZO
• UDI-Device Identifier: 09420012413406
• UDI-Public: (01)09420012413406(10)2104021357(11)251023(17)281023
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: BC192-05
• Device Catalogue Number: BC192-05
• Device Lot Number: 2104021357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2025
• 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