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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 OJR412
Device Problems Material Disintegration (1177); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4) the complaint ojr418 optiflow junior 2 nasal cannula is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
 
Event Description
A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that one of the prongs of an ojr412 optiflow junior 2 nasal cannula was disintegrated 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 ojr412 optiflow junior 2 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 one of the prongs was missing while the other edge of the other prong was rough.Conclusion: we are unable to determine the cause of the reported fault.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.Manufacturing controls include inspections during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The subject ojr 412 optiflow nasal cannula would have met the required specifications.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).
 
Event Description
A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that one of the prongs of an ojr412 optiflow junior 2 nasal cannula was disintegrated during use.There was no reported patient consequence.
 
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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 Key14467395
MDR Text Key297233635
Report Number9611451-2022-00478
Device Sequence Number1
Product Code CAT
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOJR412
Device Catalogue NumberOJR412
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received09/02/2022
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
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