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)
Date of Event	08/28/2024
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 a class 1 device, therefore, exempt from pma pathway to regulatory approval method: the complaint bc190 flexitrunk infant nasal tubing was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the 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 the tubing of the bc190 flexitrunk infant nasal tubing was observed to be torn between the 8th and 9th filament from the midline connector, confirming the reported fault.Conclusion: without the return of the subject device, our investigation was unable to determine the exact cause of the observed damage.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.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the tubing of a bc190 flexitrunk infant nasal tubing was found damaged before patient use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• 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: 20403769
• Report Number: 9611451-2024-00718
• Device Sequence Number: 3379238
• Product Code: BZO
• UDI-Device Identifier: 09420012413390
• UDI-Public: (01)09420012413390(10)2102892063(11)231121(17)261121
• 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): 09/11/2024

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: 2102892063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• 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