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

Model Number	OPT316
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2023
Type of Reportable Event	Malfunction
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 opt316 optiflow junior nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.F&p have made multiple attempts to obtain further information with regards to the reported event, however no further information was provided by the customer.Our investigation is thus based on the initial information provided by the customer and our knowledge of the product.Results: the customer reported that the tubing of an opt316 optiflow junior nasal cannula was broken during use.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All optiflow junior cannula are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken hourly from each run and pull tested to check glue joint strength at the cannula/tube joint, as well as the swivel grip joint.If there are any failures the entire batch is put aside for further investigation.The subject opt316 optiflow junior nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt316 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 regulatory body reported on behalf of a healthcare facility in the united kingdom that the tubing of an opt316 optiflow junior nasal cannula was snapped on one side during use.There was no observed force or trauma.There were no reported patient consequences.
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 cannula.Section d2b: product code updated to btt.Section d4: udi details updated - expiration date added.Section g1: contact person updated to (b)(6).Section g4: pma/510(k) number updated to k162553.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 opt316 optiflow junior nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.F&p have made multiple attempts to obtain further information with regards to the reported event, however no further information was provided by the customer.Our investigation is thus based on the initial information provided by the customer and our knowledge of the product.Results: the customer reported that the tubing of an opt316 optiflow junior nasal cannula was broken during use.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All optiflow junior cannula are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken hourly from each run and pull tested to check glue joint strength at the cannula/tube joint, as well as the swivel grip joint.If there are any failures the entire batch is put aside for further investigation.The subject opt316 optiflow junior nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt316 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 regulatory body reported on behalf of a healthcare facility in the united kingdom that the tubing of an opt316 optiflow junior nasal cannula was snapped on one side during use.There was no observed force or trauma.There were no reported patient consequences.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: NASAL CANNULA
• 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: 18136206
• Report Number: 9611451-2023-01069
• Device Sequence Number: 16843460
• Product Code: BTT
• UDI-Device Identifier: 09420012432292
• UDI-Public: (01)09420012432292(10)2102498825(11)230128(17)260128
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023
• 2 Devices were Involved in the Event: 1 2

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: 01/28/2026
• Device Model Number: OPT316
• Device Catalogue Number: OPT316
• Device Lot Number: 2102498825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2023
• 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