MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER AND PAYKEL HEALTHCARE; CANNULA, NASAL, OXYGEN

Model Number	OPT314
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We, fisher & paykel healthcare (f&p) are in the process of completing our investigation.We have received the subject device for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in germany reported via a fisher & paykel healthcare (f&p) representative that the opt314 optiflow junior neonatal nasal cannula's tubing was detached from the swivel grip joint.It was further reported that the failure was identified due to the patient's tachypnoea.The healthcare facility further reported that there was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Section g4: pma/510(k) number - no 510(k) number included due to the subject device being exempt from pms pathway to regulatory approval.Method: the complaint device opt314 optiflow junior neonatal nasal cannula 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 customer and our knowledge of the product.Results: visual inspection of the returned cannula revealed that one of the tubes was detached from the swivel grip joint with the visible glue residue on surface of the detached tube end and inside the swivel grip joint.Conclusion: the cause of the reported malfunction is identified to be insufficient glue application during manufacturing.Fisher & paykel healthcare has completed the failure investigation for the identified root cause.As a result, corrective actions were implemented in may 2024 to avoid the insufficient glue application during manufacturing.The complaint device opt314 optiflow junior neonatal nasal cannula with lot# 2103034064 was manufactured on 11 mar 2024 which is prior to corrective action implementation.The optiflow junior nasal cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and pediatric patients.It features adhesive pads (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior nasal cannula.They also state the following: appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.Do not wrap, insulate, stretch, or crush the tubing as this may impair the performance of this product or compromise safety (including potentially causing patient harm).Ensure all connections are secure during use.Check the cannula is undamaged and that the flow path is maintained.Under excessive load, the cannula may disconnect to prevent forces being transferred to the patient.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the opt314 optiflow junior neonatal nasal cannula's tubing was detached from the swivel grip joint.It was further reported that the failure was identified due to the patient's tachypnoea.The healthcare facility further reported that there was no patient consequence.

• Brand Name: FISHER AND PAYKEL HEALTHCARE
• Common Device Name: CANNULA, NASAL, OXYGEN
• 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: 20154063
• Report Number: 9611451-2024-00651
• Device Sequence Number: 8301094
• Product Code: CAT
• UDI-Device Identifier: 09420012432285
• UDI-Public: (01)09420012432285(10)2103034064(11)240311(17)270311
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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 Expiration Date: 03/11/2024
• Device Model Number: OPT314
• Device Catalogue Number: OPT314
• Device Lot Number: 2103034064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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