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

Model Number BC2755

Device Problems Detachment Of Device Component (1104); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complaint bc2755-20 intermediate infant oxygen therapy nasal cannula is manufactured by salter labs in (b)(4), for fisher & paykel healthcare.We are still endeavouring to retrieve the bc2755-20 cannula.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported to via a fisher & paykel healthcare (fph) field representative that the connection between the prongs and tubing of a bc2755-20 intermediate infant oxygen therapy nasal cannula had split.This was found after 2 days of use.There was no patient consequence.

Manufacturer Narrative

(b)(4).The complaint (b)(4) intermediate infant oxygen therapy nasal cannula is manufactured by (b)(4), for f&p.Method: the complaint (b)(4) cannula was returned to f&p in new zealand for evaluation where it was visually inspected.Result: visual inspection revealed that the left tube had detached from the nose piece and was coated with a sticky substance.The right tube was attached to the nose piece and was coated with a sticky substance.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.It appears that either insufficient bonding agent was applied to the cannula during manufacturing or that the bonding material applied had not bonded properly.A cannula from a similar complaint was sent to salter labs and they implemented a number of corrective actions including improvement of the gluing process and evaluating and replacing any damaged glue dispensers.The manufacturer of this device has been notified of this complaint and is conducting their own investigation.

Event Description

A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the connection between the prongs and tubing of a bc2755-20 intermediate infant oxygen therapy nasal cannula had split.This was found after 2 days of use.There was no patient consequence.

• 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 2013 ; NZ 2013
• MDR Report Key: 7272190
• MDR Text Key: 100279783
• Report Number: 9611451-2018-00111
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1