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

Model Number OPT318

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare 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 distributor in china reported on behalf of a healthcare facility that an opt318 optiflow junior nasal cannula tubing was damaged during use.There were no reported patient consequences.

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 received at fisher & paykel healthcare (f&p) new zealand where it was visually inspected by a trained f&p technician.Results: visual inspection of the complaint opt318 junior nasal cannula revealed that the tubing was torn, and part of the swivel grip was removed from the cannula.Conclusion: we are unable to determine the cause of the reported event.However, the most likely cause of the reported event is the tubing being pulled.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 distributor in china reported on behalf of a healthcare facility that an opt318 optiflow junior nasal cannula tubing was damaged during use.There were no reported patient consequences.

Manufacturer Narrative

Ps402642.The following additional information and corrections have been added; b5: further information was received via nmpa report system on 30 dec 2022, that the patient desaturated but after replacing the damaged cannula, the patient recovered to a stable position.G2: other: china regulatory authority (nmpa).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 received at fisher & paykel healthcare (f&p) new zealand where it was visually inspected by a trained f&p technician.Results: visual inspection of the complaint opt318 junior nasal cannula revealed that the tubing was torn, and part of the swivel grip was removed from the cannula.Conclusion: we are unable to determine the cause of the reported event.However, the most likely cause of the reported event is the tubing being pulled.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 distributor in china reported on behalf of a healthcare facility that an opt318 optiflow junior nasal cannula tubing was damaged during use.Further information was received via china nmpa report system on (b)(6) 2022, that the patient desaturated but after replacing the damaged cannula, the patient recovered to a stable position.There were no reported patient consequences.

• 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 Key: 15229845
• MDR Text Key: 298037285
• Report Number: 9611451-2022-00753
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012432308
• UDI-Public: (01)09420012432308(10)2102030790(11)220212
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT318
• Device Catalogue Number: OPT318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2022
• 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
• Treatment: PT101 AIRVO HUMIDIFIER; PT101 AIRVO HUMIDIFIER