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

Model Number	BC192
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
Event or Problem Description
A healthcare facility in australia reported, via a fisher & paykel healthcare (f&p) field representative, that the bc192 flexitrunk infant nasal tubing was found to be torn causing air to escape there were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).We have requested the return of the complaint bc192 flexitrunk infant nasal tubing for investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that a bc192 flexitrunk infant nasal tubing was found to be torn, causing air to escape.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4) corrections.Method: the complaint bc191 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 healthcare facility, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the provided photograph was unable to confirm the reported fault, as the reported damage was not visible on the photos.Conclusion: without the return of the complaint device, our investigation was unable to determine the cause of the observed damage to the bc191 flexitrunk infant nasal tubing.All bc191 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 bc191 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 bc191 bubble cpap system.

• Brand Name: FLEXITRUNK INFANT NASAL TUBING
• Common Device Name: BZO
• 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: 18540444
• Report Number: 9611451-2024-00035
• Device Sequence Number: 8915309
• Product Code: BZO
• UDI-Device Identifier: 09420012432476
• UDI-Public: (01)09420012432476(10)2102483276(11)230116
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: BC192
• Device Catalogue Number: BC192
• Device Lot Number: 2102483276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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