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

Model Number	BC191-05
Medical Device Problem Codes	Break (1069); 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).Section g4: pma/510(k) number - no 510(k) number included due to the subject device being exempt from pms 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.
Event or Problem Description
A healthcare facility in taiwan reported that the tubing of a bc191-05 flexitrunk nasal tubing 70mm was broken.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Section g4: pma/510(k) number - no 510(k) number included due to the subject device being exempt from pms pathway to regulatory approval.Method: the subject device, bc191-05 flexitrunk nasal tubing was returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is 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 returned device showed that the film in one of the tubes was stretched near the end that connects to the breathing circuit.Furthermore, a soak test was performed to assess whether the tube was damaged, and results confirmed that the tube was not broken.Conclusion: upon investigation of the returned device, it was confirmed that the tubing was not broken as initially reported by the customer.Instead, the film was stretched.Our user instructions which accompany the bc191-05 flexitrunk nasal tubing system state: 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." a caution insert is included in the packaging to remind the user to take extra care when handling the bc191-05 flexitrunk infant nasal tubing.
Event or Problem Description
A healthcare facility in taiwan reported that the tubing of a bc191-05 flexitrunk nasal tubing was broken.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: 23565702
• Report Number: 9611451-2025-01445
• Device Sequence Number: 10272747
• Product Code: BZO
• UDI-Device Identifier: 09420012432469
• UDI-Public: (01)09420012432469(10)2103703421(11)250401(17)280401
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 02/20/2026

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: BC191-05
• Device Catalogue Number: BC191-05
• Device Lot Number: 2103703421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/16/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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