MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INTERMEDIATE INFANT OXYGEN THERAPY NASAL CANNULA; CAT

Model Number BC2755

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the healthcare facility to determine if the complaint bc2755 intermediate infant oxygen therapy nasal cannula caused or contributed to the reported event.We are also attempting to obtain the subject complaint device for further investigation.We will provide a follow up report once we have completed our evaluation.

Event Description

A healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the tubing of a bc2755 intermediate infant oxygen therapy nasal cannula detached from the prongs.This was found before use on a patient.

Manufacturer Narrative

(b)(4).The complaint bc2755-20 neonatal oxygen therapy nasal cannula is manufactured by (b)(4), for fisher & paykel healthcare.Method: three complaint devices were returned to fisher & paykel healthcare in (b)(4) for investigation where they were visually inspected.Results: visual inspection revealed that for device #1 the detached left and right tubes without the nose piece were returned, for device #2 the right tube was detached from the nose piece and for device #3 no visual damage was observed.Conclusion: during manufacture by (b)(4), 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 healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the tubing of a bc2755 intermediate infant oxygen therapy nasal cannula detached from the prongs.This was found before use on a patient.

• Brand Name: INTERMEDIATE INFANT OXYGEN THERAPY NASAL CANNULA
• Type of Device: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: jonathan stevens ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6363391
• MDR Text Key: 68757199
• Report Number: 9611451-2017-00143
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC2755
• Device Catalogue Number: BC2755
• Device Lot Number: 160822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• 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