MAUDE Adverse Event Report: OPTIFLOW JUNIOR INTERFACE; CAT

Model Number	OPT312
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6) that the interface of an opt312 optiflow junior cannula was found broken after two days of use.There was no reported patient consequence.
Additional Manufacturer Narrative
Ps378741, the optiflow junior 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 opt312 optiflow junior nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information, and photograph provided by the customer, previous investigations of similar complaints and our knowledge on the product.Results: visual inspection of the provided photograph revealed that the cannula was broken between the nasal prongs.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 opt312 optiflow junior nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt312 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 distributor reported on behalf of a healthcare facility in china that the interface of an opt312 optiflow junior cannula was found broken after two days of use.There was no reported patient consequence.

• Brand Name: OPTIFLOW JUNIOR INTERFACE
• Common Device Name: CAT
• MDR Report Key: 12557990
• Report Number: 9611451-2021-01085
• Device Sequence Number: 4584321
• Product Code: CAT
• UDI-Device Identifier: 09420012432278
• UDI-Public: (01)09420012432278(10)2101342323(11)201016
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: OPT312
• Device Catalogue Number: OPT312
• Device Lot Number: 2101342323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• 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