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)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Section d4: serial number intentionally left blank as the information is not applicable.Section g4: no 510(k) number was included due to the subject device being exempt from pma pathway to regulatory approval.Method: the subject bc192 flexitrunk infant nasal tubing was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information, photograph and description of events provided by the customer, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the provided photograph revealed that one of the tubing of the bc192 flexitrunk infant nasal tubing, was observed torn on the circuit end side, confirming the reported fault.Conclusion: without the subject device, we are unable to determine the exact cause of the reported fault.All flexitrunk nasal tubing are visually inspected, and pressure tested before leaving the production line, those that fail are rejected.This suggests that the damage on the subject nasal tubing occurred after it was released for distribution.Our user instructions which accompany the bc192 flexitrunk nasal tubing system state: "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." a caution insert is included in the packaging to remind the user to take extra care when handling the bc192 flexitrunk nasal tubing.
Event or Problem Description
A distributor in china reported on behalf of a healthcare facility that the tubing of a bc192-05 flexitrunk infant nasal tubing was found broken during use on a patient.There were no reported patient consequences.

• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 21587578
• Report Number: 9611451-2025-00202
• Device Sequence Number: 21136648
• Product Code: BZO
• UDI-Device Identifier: 09420012413406
• UDI-Public: (01)09420012413406(10)2102063985(11)220302(17)250302
• 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): 02/11/2025

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 Expiration Date: 03/02/2025
• Device Model Number: BC192-05
• Device Catalogue Number: BC192-05
• Device Lot Number: 2102063985
• 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: 02/11/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2022
• 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