MAUDE Adverse Event Report: FISHER & PAYKEL HEATHCARE 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	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Section g4: no 510(k) number was included in section g4 of the report because the device is exempted from pma pathway to regulatory approval.Method: the subject device, bc191-05 flexitrunk nasal tubing was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photography provided by the healthcare facility, and our knowledge of the product.Results: evaluation of the photography provided reveals the device setup, however the reported event is not visible from the photography.The healthcare facility reported that the tubing of subject device was cracked.Conclusion: we are unable to confirm the cause of the reported event.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: "always use pressure monitoring to verify that the patient is receiving the prescribed cpap level." "handle with care.Use caution when positioning or disconnecting the 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.
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 cracked during use.There was no reported patient consequence.
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 cracked during use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Section g4: no 510(k) number was included in section g4 of the report because the device is exempted from pma pathway to regulatory approval.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 based on the information and photography provided by the distributor, and our knowledge of the product.Results: evaluation of the provided information and photography revealed that the device tubing was broken and was wrapped in medical tape.Conclusion: without the subject device being returned for evaluation, the exact cause of the reported event could not be determined.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: "always use pressure monitoring to verify that the patient is receiving the prescribed cpap level." "handle with care.Use caution when positioning or disconnecting the 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.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: NASAL TUBING
• Manufacturer (Section D): FISHER & PAYKEL HEATHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEATHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego vargus banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 24242854
• Report Number: 9611451-2026-00384
• Device Sequence Number: 8309414
• Product Code: BZO
• UDI-Device Identifier: 09420012413635
• UDI-Public: (01)09420012413635(10)2103757040(11)250507(17)280507
• 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,Followup
• Report Date (Section B): 03/03/2026

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: Health Professional
• Device Model Number: BC191-05
• Device Catalogue Number: BC191-05
• Device Lot Number: 2103757040
• 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: 01/04/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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