MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; CAT

Model Number OPT844

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that the silicone strap detached from an opt844 nasal cannula, causing leak.The hospital also stated that this had happeneed with several cannulae.They confirmed that there was no patient consequence.

Manufacturer Narrative

(b)(4).The complaint opt844 nasal cannulae are en route to fisher & paykel healthcare (b)(6) for evaluation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).The opt844 interface is used to deliver humidified oxygen to patients.The opt844 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.Method: four opt844 nasal cannulae were received at fisher & paykel healthcare in (b)(4).Three devices were from lot 141127 (manufactured november 27 2014) and one was from lot 150211 (manufactured february 11 2015).The returned cannulae were visually inspected.Results: no fault was found with device 1.In device 2, the nasal prong was found disconnected on one side of the manifold.In device 3, the nasal prong was found loose on one side of the manifold.Device 4 was found sealed and unused with no fault found.A lot check revealed no other complaints of this nature for either of the lot numbers provided.Conclusions: the cannula manifold coming loose from the nasal interface can be caused by tightening the silicone buckle too firmly when adjusting the headstrap.All cannulas are visually inspected for cracks, tears, inclusions, discolouration and deformation prior to leaving production and those that fail are rejected.Our user instructions that accompany the product illustrate the procedure for fitting the optiflow nasal cannula to a patient.

Event Description

A hospital in (b)(6) reported that the silicone strap detached from an opt844 nasal cannula, causing leak.The hospital also stated that this had happened with several cannulae.They confirmed that there was no patient consequence.

• Brand Name: ADULT NASAL 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 ; 9194534000
• MDR Report Key: 4889626
• MDR Text Key: 16310485
• Report Number: 9611451-2015-00301
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT844
• Device Catalogue Number: OPT844
• Device Lot Number: 141127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2014
• 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