MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-27 for OPTIFLOW JUNIOR 2 CANNULA OJR418 manufactured by Fisher & Paykel Healthcare Ltd.
[183964772]
(b)(4). Method: the complaint device was not returned to fisher & paykel healthcare (f&p) for evaluation. Our investigation is thus based on the photography and information provided by the customer and our knowledge of the product. Results: visual inspection of the photography provided by the customer revealed that both sides of the tubing were stretched near the swivel grip. It was further reported that the patient had "rotated the device". Conclusion: the stretched tubing is most likely caused by the patient accidentally pulling at the tubing. All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded. In addition, a tube tensile strength test is carried out and if the tube breaks before the load of 10 newtons is reached the entire batch is scrapped. Samples are also taken from each run and pull tested to check glue joint strength at the cannula/tube joint, as well as the swivel grip joint. The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 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).
Patient Sequence No: 1, Text Type: N, H10
[183964773]
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr418 optiflow junior 2 nasal cannula was broken during use. There was no reported patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00218 |
| MDR Report Key | 9767516 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLOW JUNIOR 2 CANNULA |
| Generic Name | CAT |
| Product Code | CAT |
| Date Received | 2020-02-27 |
| Model Number | OJR418 |
| Catalog Number | OJR418 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |