MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR INTERFACE; BTT

Model Number OPT316

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in united kingdom reported via the medicines and healthcare products regulatory agency (mhra ) that the tubing of an opt316 optiflow junior cannula was broken.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).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 (wagglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs, and breathable kink-proof, and crush-resistant flexible tubing.Method: the opt316 optiflow junior nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of our product.Results: the customer reported that the tubing of the opt316 optiflow junior nasal cannula was detached.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.Samples are also taken and pull tested to check the tube tensile strength and the glue joint strength at the cannula/ tube joint, as well as the swivel grip joint.The subject cannula would have met the required specifications at the time of production.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 from being transferred to the patient.-ensure the patient does not lie on the tubing as this may apply pressure to the patient's ears or face.-failure to apply and use this product within the directions, transport, storage and operating conditions specified in the labelling and user instructions may impair the performance of this product or compromise safety (including potentially causing serious patient harm.).

Event Description

A healthcare facility in united kingdom reported via the medicines and healthcare products regulatory agency (mhra ) that the tubing of an opt316 optiflow junior cannula was broken.There was no reported patient involvement.

• Brand Name: OPTIFLOW JUNIOR INTERFACE
• Type of Device: BTT
• 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: omid tajeri ; 17400 laguna canyon road; suite 300; irvine, CA 42618
• MDR Report Key: 19169764
• MDR Text Key: 341589939
• Report Number: 9611451-2024-00324
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012432292
• UDI-Public: (01)09420012432292(10)2102762211(11)230831
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Model Number: OPT316
• Device Catalogue Number: OPT316
• Device Lot Number: 2102762211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1