MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR 2 BLENDER TRANSITION KIT; BTT

Model Number	OJR416B
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint ojr416b optiflow junior 2 blender transition kit was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected.Our investigation is thus based on the evaluation of the subject device, the information provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the complaint device revealed that the tubing was found torn next to the left swivel grip end, with part of the tubing still attached to the inside of the swivel.It was also observed that part of the tubing was stretched out.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the ojr416b optiflow junior 2 blender transition kit.Based on our knowledge of the product, the damage is most likely caused due to the tubing being inadvertently pulled and subjected to excessive force.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 ojr416b optiflow junior 2 blender transition kit would have met the required specifications at the time of release.The user instructions which accompany the ojr416b optiflow junior 2 blender transition kit show in pictorial format the correct placement and fitting of the cannula, and provide the following warnings: "appropriate patient monitoring (e.G., oxygen saturation) must be used at all times.Failure to monitor the patient may result in loss of therapy, serious harm or death." "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." "do not stretch the cannula on application; this may cause increase pressure to the patient's skin.If necessary, the cannula may be repositioned.".
Event or Problem Description
During device evaluation of an ojr416b optiflow junior 2 blender transition kit at fisher & paykel healthcare (f&p) new zealand, it was found that the tubing was broken at the swivel joint.There was no patient consequence.

• Brand Name: OPTIFLOW JUNIOR 2 BLENDER TRANSITION KIT
• Common Device Name: 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20072165
• Report Number: 9611451-2024-00601
• Device Sequence Number: 11512737
• Product Code: BTT
• UDI-Device Identifier: 09420012448897
• UDI-Public: (01)09420012448897(10)2102449394(11)221204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2024

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
• Operator of Device: Health Professional
• Device Model Number: OJR416B
• Device Catalogue Number: OJR416B
• Device Lot Number: 2102449394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown