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

Model Number	BC191-05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in china reported on behalf of a healthcare facility that the tubing of a bc191-05 flexitrunk nasal tubing was torn before being used on a patient.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(6).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 thus based on the information and photography provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the provided photography confirmed that the film within the tubing was torn and stretched near the connector.The film also appeared wrinkled and torn indicating that the tubing may have been subjected to pulling or overextension.Conclusion: based on the visual inspection of the provided photography, information provided by the customer and our knowledge of the product, it is most likely that the reported event resulted from the subject 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 bc191-05 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.Section g4: pma/510(k) number - no 510(k) number included due to the subject device being exempt from pms pathway to regulatory approval.

• 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: 23707232
• Report Number: 9611451-2025-01752
• Device Sequence Number: 10629325
• Product Code: BZO
• UDI-Device Identifier: 09420012413635
• UDI-Public: (01)09420012413635(10)2103745596(11)250430(17)280430
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: BC191-05
• Device Catalogue Number: BC191-05
• Device Lot Number: 2103745596
• 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: 11/07/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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