MAUDE Adverse Event Report: PATIENT INTERFACE NASAL PRONGS; BZO

Model Number BC6070

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 (b)(4) 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 bc6070 nasal prongs disconnected from the nasal tubing during use.There was no patient consequence.

Event Description

A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that the bc6070 nasal prongs disconnected from the nasal tubing during use.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint bc6070 nasal prongs were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based off the information reported by the customer and our knowledge of the product.Results: the customer reported that the bc6070 nasal prongs disconnected from the nasal tubing during use.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.The flexitrunk infant interface user instruction state the following: "connect prongs or mask to nasal tubing ensuring that it is inserted fully"."always use pressure monitoring to verifty that the patient is receiving the prescribed cpap level"."handle with care.Use caution when positioning or disconnecting the infant interface.Avoid excessive pull forces, sharp objects and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement".

• Brand Name: PATIENT INTERFACE NASAL PRONGS
• Type of Device: BZO
• MDR Report Key: 10916262
• MDR Text Key: 219177411
• Report Number: 9611451-2020-01062
• 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: 11/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC6070
• Device Catalogue Number: BC6070
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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