MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED OPTIFLOW JUNIOR NASAL CANNULA; CAT

Model Number OPT316

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint opt316 optiflow junior nasal cannula was returned to fph in (b)(4) and was visually inspected.Results: visual inspection revealed one of the tubes was detached from the swivel grip, confirming the reported fault.Conclusion: the observed damage was most likely the result of pulling on the tube with undue force.All optiflow junior cannulae 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 user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior nasal cannula.They also state the following: - "ensure that all connections are secure during use.Check cannula is undamaged and that the flow path is maintained." - "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." as part of our ongoing product improvement initiatives, fph implemented additional testing and checking on the optiflow junior production line to further ensure that all product leaving the line meets specification.

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that one of the tubes of an opt316 optiflow junior nasal cannula became detached from the swivel grip after two hours of use.No patient consequence was reported.

• Brand Name: OPTIFLOW JUNIOR NASAL CANNULA
• Type of Device: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: irfanali kermalli ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6727260
• MDR Text Key: 80700645
• Report Number: 9611451-2017-00657
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT316
• Device Catalogue Number: OPT316
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Date Manufacturer Received: 06/24/2017
• 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 Number: 1
• Patient Outcome(s): Required Intervention