MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR CANNULA; CAT

Model Number OPT316

Device Problem Break (1069)

Patient Problem Rash (2033)

Event Date 07/24/2023

Event Type  malfunction  

Event Description

A healthcare facility in china reported that an opt316 optiflow junior nasal cannula was found to be torn during use.The healthcare facility mentioned that the patient tore the opt316 optiflow junior nasal cannula.The patient experienced a rash around the nose, mouth, and auricle areas.The rash was treated with an erythromycin ointment and the patient recovered.Furthermore, fisher and paykel healthcare (f&p) field representative reported that the healthcare facility disinfected the opt316 optiflow junior nasal cannula by alcohol and they reused the same opt316 optiflow junior nasal cannula on four different patients.

Manufacturer Narrative

(b)(4).Method: the complaint opt316 optiflow junior nasal cannula was not received at fisher & paykel healthcare (f&p) for investigation.Our investigation was thus based on the information provided by the customer, previous investigations of similar complaints, and our knowledge on the product.Results: the customer reported that an opt316 optiflow junior nasal cannula was broken by the patient during use.It was also reported that the opt316 optiflow junior nasal cannula had been disinfected by alcohol and reused multiple times on different patients, which is against the user instructions.The customer also confirmed that the clinical department discarded the opt316 optiflow junior nasal cannula after the event.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.However, it is most likely a damage caused by the patient and due to the multiple disinfection and reuse, which is against user instructions.The opt316 optiflow junior nasal cannula is only to be used for single patient use.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 must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.-do not stretch or crush tube.-do not soak, wash, sterilise, or re-use this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.-reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death.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 specification at time of production.

• Brand Name: OPTIFLOW JUNIOR CANNULA
• Type of Device: CAT
• 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 taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17647029
• MDR Text Key: 322295112
• Report Number: 9611451-2023-00801
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: F&P 900PT561 HEATED BREATHING TUBE; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Age: 3 YR