MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD CANNULA O2 THERAPY PREMATURE; CAT

Model Number BC2425-20

Device Problem Device Issue (2379)

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

Event Date 12/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The bc2425 oxygen therapy nasal cannula is manufactured by (b)(4), for fisher & paykel heathcare.The complaint bc2425 oxygen therapy nasal cannula is currently en-route to fisher & paykel healthcare in (b)(4) for evaluation, to determine if it caused or contributed to the reported event.We will submit a follow-up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported that the "the specs part of the interface" of a bc2425-20 neonatal nasal cannula has disconnected from the rest of the plastic.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint bc2425-20 neonatal oxygen therapy nasal cannula is manufactured by (b)(4), for fisher & paykel healthcare.Method: the complaint device was returned to fisher & paykel healthcare in (b)(4) for investigation where it was visually inspected.Results: upon visual inspection it was noted that the pvc tube had detached from the right side of the nose piece.There was evidence of glue on the surface of the nose piece.There was no evidence of damage to the surface of the tubing.Conclusion: during manufacture by salter labs, a bonding agent is applied to the outside surface of the tube and then inserted into the nasal interface.This is a manual process.As there was no damage to the surface of the tubing, it appears that either insufficient bonding agent was applied to the cannula during manufacturing or that the bonding material applied had not bonded properly, as a bond broken by force would have caused damage to the tube surface.The manufacturer of this device has been notified of this complaint and is conducting their own investigation.

Event Description

A hospital in the (b)(6) reported that the "the specs part of the interface" of a bc2425-20 neonatal nasal cannula has disconnected from the rest of the plastic.No patient consequence was reported.

• Brand Name: CANNULA O2 THERAPY PREMATURE
• 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: jonathan stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6281548
• MDR Text Key: 65899156
• Report Number: 9611451-2017-00048
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC2425-20
• Device Catalogue Number: BC2425-20
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• 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