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

Model Number OPT318

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint opt318 optiflow junior nasal cannula is expected, but has not yet been returned to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported via a fisher & paykel healthcare representative that the tubing of the opt318 optiflow junior nasal cannula broke away from the connector.It was further reported that "the patient was agitated and was pulling which may have contributed to the damage".No patient consequence was reported.

Event Description

A hospital in the uk reported via a fisher & paykel healthcare representative that the tubing of the opt318 optiflow junior nasal cannula broke away from the connector.It was further reported that "the patient was agitated and was pulling which may have contributed to the damage".No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint: opt318 optiflow junior nasal cannula was returned to fisher & paykel healthcare in new zealand for investigation where it was visually inspected.Results: visual inspection of the complaint cannula confirmed that the right tube was pulled out of the swivel grip.Conclusion: the damage to the cannula is likely to have been caused by excessive pulling force being exerted on the tubing.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 monitoring must be used at all times.Do not stretch or crush tube.

• Brand Name: OPTIFLOW JUNIOR INTERFACE
• Type of Device: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8053890
• MDR Text Key: 127361432
• Report Number: 9611451-2018-00950
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

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 Number: OPT318
• Device Catalogue Number: OPT318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1