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

Model Number OPT318

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that an opt318 optiflow junior nasal cannula tubing was separating from the swivel grip and causing leak.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint op318 cannula was returned to fisher & paykel healthcare for evaluation and was visually inspected.Results: visual inspection of the returned cannula revealed that both flexitubes (cannula tubing) were damaged where they connect to the breathing circuit.The tubing was stretched and broken but the metal spring was still attached.Conclusion: we were unable to determine what had caused the damage to the flexitubes, but it was likely caused by excess 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 currently 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4900906
• MDR Text Key: 6534287
• Report Number: 9611451-2015-00307
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• 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: 07/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2015
• 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