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

Model Number	BC192-05
Medical Device Problem Code	Gas/Air Leak (2946)
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 a bc192 flexitrunk infant nasal tubing was noisy and leaking air.It's also reported that when they hand over the area, leaking noise reduces.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).The complaint bc192 flexitrunk infant nasal tubing is currently en route to fisher and paykel healthcare (f&p) for investigation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the complaint bc192 flexitrunk infant nasal tubing was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and water bath tested.Results: visual inspection and testing of the returned complaint bc192 flexitrunk infant nasal tubing revealed that there were no tears or audible leak noise observed on the tubing of the bc192 flexitrunk infant nasal tubing.Conclusion: we are unable to determine the cause of the reported fault as there was no fault found with the returned device.All flexitrunk nasal tubings are visually inspected and pressure tested before leaving the production line and those that fail are rejected.Our user instructions the accompany the flexitrunk infant nasal tubing state: use caution when positioning 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 flexitrunk.
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 noisy and leaking air.It was also reported that when they covered the area, leaking noise reduced.There was no patient consequence.
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 noisy and leaking air.It's also reported that when they hand over the area, leaking noise reduces.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only: corrections to reflect gudid: section d1: brand name updated to fisher & paykel healthcare; section d2a: common device name updated to nasal tubing; section d4: model and catalog # updated to bc192-05; section g1: contact person updated to mr.(b)(4).Section g4: no 510(k) number was included in section g4 of the report because the device is a class 1 device and exempt from pma pathway to regulatory approval method: the complaint bc192 flexitrunk infant nasal tubing was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and water bath tested.Results: visual inspection and testing of the returned complaint bc192 flexitrunk infant nasal tubing revealed that there were no tears or audible leak noise observed on the tubing of the bc192 flexitrunk infant nasal tubing.Conclusion: we are unable to determine the cause of the reported fault as there was no fault found with the returned device.All flexitrunk nasal tubings are visually inspected and pressure tested before leaving the production line and those that fail are rejected.Our user instructions the accompany the flexitrunk infant nasal tubing state: - "use caution when positioning 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 flexitrunk.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: NASAL TUBING
• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 18008920
• Report Number: 9611451-2023-01010
• Device Sequence Number: 12591299
• Product Code: BZO
• UDI-Device Identifier: 09420012432476
• UDI-Public: (01)09420012432476(10)2102503335(11)230202(17)260202
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2023

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 Expiration Date: 02/02/2026
• Device Model Number: BC192-05
• Device Catalogue Number: BC192-05
• Device Lot Number: 2102503335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 12/10/2023; 12/10/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/18/2023; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SLE 6000 VENTILATOR.; SLE 6000 VENTILATOR.; SLE 6000 VENTILATOR.
• Patient Sex: Unknown