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

Model Number OPT944

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt944 interface is used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip to support the weight of the circuit and prevent the cannula being dislodged.Method: one complaint cannula and three unused unopened cannulae were received and were visually inspected.Results: visual inspection of the complaint cannula revealed that the tubing had become detached from the swivel connector.The swivel connector was tested and found to be fully functional.Visual inspection of the unused cannulae revealed no defects.The swivel connector was firmly attached and did not detach when manipulated.Conclusion: the observed damage is most likely the result of pulling on the cannula tubing with undue force.The hospital had informed us that the tubing may have been pulled by the patient.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.The setup instructions in the user instructions which accompany the opt944 nasal cannula include the following steps: ensure head strap clip is attached, to prevent cannula from being pulled out of the nares; cannula can become unattached if not used with the head strap clip; attach tubing clip to clothing/bedding to prevent cannula from pulling off face.The user instructions also contain the following warnings/cautions: do not crush or stretch tube, to prevent loss of therapy; failure to use the set-up described above can compromise performance and affect patient safety.Our optiflow production team has been notified of this failure.They have carried out an internal investigation of the manufacturing process and production staff have received additional training to ensure they are following the correct assembly procedure.

Event Description

A hospital in (b)(6) reported that the opt944 nasal cannulae broke where the tubing attaches to the breathing circuit.No patient consequence was reported.

• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 5680775
• MDR Text Key: 45960273
• Report Number: 9611451-2016-00229
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: 160210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2016
• 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