MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; NASAL TUBING 100MM

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)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Method: the subject device bc192-05 flexitrunk infant nasal tubing was not returned to the fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph revealed the tubing is broken.Conclusion: without the complaint device being available for evaluation, we are unable to determine the cause of the reported event.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 france reported via a fisher & paykel healthcare (f&p) field representative that the tubing of a bc192-05 flexitrunk infant nasal tubing was broken.There was no reported patient involvement.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: NASAL TUBING 100MM
• 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: 23306545
• Report Number: 9611451-2025-01027
• Device Sequence Number: 20072352
• Product Code: BZO
• UDI-Device Identifier: 09420012413406
• UDI-Public: (01)09420012413406(10)2103062750(11)240328(17)270328
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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: BC192-05
• Device Catalogue Number: BC192-05
• Device Lot Number: 2103062750
• 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: 09/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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