MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED 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 two bc192 flexitrunk infant nasal tubings were found to be torn, causing air to escape.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Device 1 lot# unknown.Device 2 lot# 2102483276.Method: the two complaint bc192 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 devices revealed that the tubing was found torn, confirming the reported fault.Visual inspection of device 1 (lot# unknown) confirmed torn damage to the middle of the tubing.Visual inspection of device 2 (lot# 2102483276) confirmed that the tubing was torn between the fourth and fifth from the connector side.The film of the both devices revealed that the tubing was wrinkled, which indicates that the tubings have had force applied, deformed, and then broken.Thus, the subject devices have been pulled to an unintended extension.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the subject bc192 flexitrunk infant nasal tubing devices.Based on our knowledge of the product the tubing was likely subjected to excessive force.All bc192 bubble cpap systems 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 bc192 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 bc192 bubble cpap system.

• Brand Name: FLEXITRUNK INFANT NASAL TUBING
• Common Device Name: BZO
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 18540437
• Report Number: 9611451-2024-00034
• Device Sequence Number: 21061620
• Product Code: BZO
• UDI-Device Identifier: 09420012413406
• UDI-Public: (01)09420012413406(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: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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