MAUDE Adverse Event Report: PATIENT INTERFACE NASAL PRONGS; BZO

Model Number BC5050

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint bc5050 nasal prongs is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the bc5050 nasal prongs disconnected from the nasal tubing during use.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the subject bc5050 flexitrunk infant nasal prongs, bc6070 flexitrunk infant nasal prongs and bc192 flexitrunk infant interface was received at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was inspected.Results: there was no fault found with the subject devices and all measurements were within specifications.Conclusion: we were unable to determine what may have caused the reported event, as no fault was found with the returned subject devices.F&p currently makes 11 different sizes of prongs and recognises that correct cannula size selection, correct prong placement and fit and careful patient monitoring are vital in ensuring the patient receives the benefits of nasal therapy.The user instructions that accompany the flexitrunk infant interface illustrate the correct interface set-up on the infant (including sizing information), and also state the following: "use the sizing guide to choose suitable prongs or mask." "prongs should fill the nares completely without stretching the skin.Use the biggest possible size." "choose the correct length of the nasal tubing.Use the shortest length possible." "connect prongs or mask to nasal tubing ensuring that it is inserted fully." "if using prongs: squeeze sides of prongs firmly to expose grooves.Start from one end and insert prong grooves into nasal tubing.Push end in firmly.".

Event Description

A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that the bc5050 nasal prongs disconnected from the flexitrunk interface during use.There was no patient consequence.

• Brand Name: PATIENT INTERFACE NASAL PRONGS
• Type of Device: BZO
• MDR Report Key: 10912628
• MDR Text Key: 219157657
• Report Number: 9611451-2020-01060
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): Y
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC5050
• Device Catalogue Number: BC5050
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: F&P RT265 DUAL LIMB INFANT BREATHING CIRCUIT; F&P RT265 DUAL LIMB INFANT BREATHING CIRCUIT