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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR 2 NASAL CANNULA; CAT
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FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR 2 NASAL CANNULA; CAT Back to Search Results
Model Number OJR414
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/17/2022
Event Type  malfunction  
Event Description
A healthcare facility in united kingdom reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr414 optiflow junior 2 nasal cannula was bent during use.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) are currently in the process of retrieving further information regarding this complaint.We will provide a follow up report upon the completion of our investigation.
 
Event Description
A healthcare facility in united kingdom reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr414 optiflow junior 2 nasal cannula was bent during use.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).The optiflow junior cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and pediatric 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 (b)(4) optiflow junior 2 nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected.Results: visual inspection of the complaint cannula revealed that the tubing was torn next to swivel grip joint.Conclusion: we are unable to determine the cause of the reported event.However, it is most likely caused by the tubing being pulled.Optiflow junior all 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.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 nasal 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).Ensure all connections are secure during use.Check the 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.
 
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Brand Name
OPTIFLOW JUNIOR 2 NASAL 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
faranak gomarooni
17400 laguna canyon road
suite 300
irvine, CA 92618
9494534002
MDR Report Key15223036
MDR Text Key298036827
Report Number9611451-2022-00750
Device Sequence Number1
Product Code CAT
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOJR414
Device Catalogue NumberOJR414
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2022
Date Manufacturer Received09/29/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
950N61 NEONATAL NON-INVASIVE SINGLE HEATED CIRCUIT; 950N61 NEONATAL NON-INVASIVE SINGLE HEATED CIRCUIT; F&P 950 HUMIDIFIER; F&P 950 HUMIDIFIER
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