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

Model Number	BC190-05
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We have requested the return of the complaint bc190 flexitrunk infant nasal tubing for investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the bc190 flexitrunk infant nasal tubing was found to be broken before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint bc190 flexitrunk infant nasal tubing was not returned to f&p for evaluation.Our investigation is based on the information and photograph 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 bc190 flexitrunk infant nasal tubing was torn on the midline side.Conclusion: without the return of the subject device, are unable to determine the cause of the reported event.All flexitrunk nasal tubings are visually inspected and pressure tested before leaving the production line and 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 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.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the bc190 flexitrunk infant nasal tubing was found broken before patient use.There was no patient involvement.
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 bc190-05.Section d4: serial number intentionally left blank as the information is not applicable.Section d4: expiration date added.Section d4: udi details updated.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 bc190 flexitrunk infant nasal tubing was not returned to f&p for evaluation.Our investigation is based on the information and photograph 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 bc190 flexitrunk infant nasal tubing was torn on the midline side.Conclusion: without the return of the subject device, are unable to determine the cause of the reported event.All flexitrunk nasal tubings are visually inspected and pressure tested before leaving the production line and 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 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.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the bc190 flexitrunk infant nasal tubing was found broken before patient use.There was no patient involvement.

• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 18264444
• Report Number: 9611451-2023-01124
• Device Sequence Number: 19822364
• Product Code: BZO
• UDI-Device Identifier: 09420012432452
• UDI-Public: (01)09420012432452(10)2102359620(11)220922(17)250922
• 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,Followup,Followup
• Report Date (Section B): 11/06/2023

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: 09/22/2025
• Device Model Number: BC190-05
• Device Catalogue Number: BC190-05
• Device Lot Number: 2102359620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 12/19/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/16/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• 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