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

Model Number	BC190-05
Medical Device Problem Code	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)(4).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 ohio reported via a fisher & paykel healthcare (f&p) field representative that the bc190 flexitrunk infant nasal tubing had a hole in the tubing.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the bc190 flexitrunk infant nasal tubing had a hole in the tubing.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Additional Manufacturer Narrative
(b)(4).Corrections: 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 a class 1 device, therefore exempt from pma pathway to regulatory approval.Method: the complaint bc190 flexitrunk infant nasal tubing was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Our investigation is thus based on the evaluation of the subject device, the information provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the complaint device revealed that the tubing was found torn between the fourth and fifth from the midline connector side.The film of the tubing was also observed to be wrinkled and torn, indicating that force was applied, the tube deformed and then broke.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the bc190 flexitrunk infant nasal tubing.Based on our knowledge of the product the tubing was likely subjected to excessive force.All bc190 bubble cpap system 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 bc190 bubble cpap 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 bc190 bubble cpap system.

• 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 ; 9494341005
• MDR Report Key: 19662274
• Report Number: 9611451-2024-00476
• Device Sequence Number: 20482034
• Product Code: BZO
• UDI-Device Identifier: 09420012413390
• UDI-Public: (01)09420012413390(10)2102947950(11)240115
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: BC190-05
• Device Catalogue Number: BC190-05
• Device Lot Number: 2102947950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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