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

Model Number	OPT314
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher and paykel (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject opt314 optiflow junior nasal cannula to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in germany, via a fisher & paykel healthcare (f&p) field representative, reported that the tubing of an opt314 optiflow junior nasal cannula was detached from the swivel grip joint during patient use.It was reported that the incident was noticed after the patient's oxygen saturation dropped.No further patient consequence was reported.Further information has been requested about the level of desaturation.
Additional Manufacturer Narrative
(b)(4).The optiflow junior nasal cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and paediatric 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.Method: the complaint opt314 optiflow junior nasal cannula was not received at fisher & paykel healthcare (f&p) in new zealand.The customer sent 36 non complaint units for investigation that were visually inspected.The investigation is thus based on the information provided by the customer and our knowledge of the product.Results: visual inspection of the returned cannulas found no fault with the units.Visual inspection of the photo provided by the customer of the original complaint device showed that the tube was detached from the left cannula joint.Conclusion: we are unable to determine the cause of the reported event as the complaint device was not returned to f&p in new zealand for investigation.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, 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.The user instructions which accompany the opt314 optiflow junior nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: ensure that all connections are secure during use.Check 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.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.
Event or Problem Description
A healthcare facility in germany, via a fisher & paykel healthcare (f&p) field representative, reported that the tubing of an opt314 optiflow junior nasal cannula was detached from the swivel grip joint during patient use.It was reported that the incident was noticed after the patient's oxygen saturation dropped.No further patient consequence was reported.F&p made multiple attempts to retrieve further information about the reported patient harm, however the customer did not provide any further information.

• Brand Name: OPTIFLOW JUNIOR CANNULA
• Common Device Name: 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16455864
• Report Number: 9611451-2023-00134
• Device Sequence Number: 15012579
• Product Code: CAT
• UDI-Device Identifier: 09420012432285
• UDI-Public: (01)09420012432285(10)2102315757(11)220823
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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 Model Number: OPT314
• Device Catalogue Number: OPT314
• Device Lot Number: 2102315757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P AIRVO 2 HUMIDIFIER; F&P AIRVO 2 HUMIDIFIER
• Patient Sex: Unknown