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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR INTERFACE; BTT

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FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR INTERFACE; BTT Back to Search Results
Model Number OPT318
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 opt318 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 and our knowledge of the product.Result: visual inspection of the provided photograph revealed that the tubing of the complaint device was detached from the swivel grip joint.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 opt318 optiflow junior nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt318 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 Description
A healthcare facility in illinois reported via a fisher and paykel (f&p) healthcare field representative that the tubing of an opt318 optiflow junior cannula was detached from the swivel grip joint before use on a patient.There was no patient involvement.
 
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Brand Name
OPTIFLOW JUNIOR INTERFACE
Type of Device
BTT
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
9494534000
MDR Report Key15831827
MDR Text Key304017800
Report Number9611451-2022-01078
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012432308
UDI-Public(01)09420012432308(10)2102146034(11)220422
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/25/2022
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
Device Operator Health Professional
Device Model NumberOPT318
Device Catalogue NumberOPT318
Device Lot Number2102146034
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/25/2022
Initial Date FDA Received11/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2022
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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