MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FLEXITRUNK INFANT NASAL TUBING; BZO

Model Number BC191

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device bc191 flexitrunk infant nasal tubing has just been received at fisher & paykel healthcare (b)(4) (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor in (b)(6) reported via a fisher & paykel healthcare representative that five units of bc191 flexitrunk infant nasal tubing have nasal prongs detaching from the tubing.There was no patient consequence reported.

Event Description

A distributor in new jersey reported via a fisher & paykel healthcare representative that five units of bc191 flexitrunk infant nasal tubing have nasal prongs detaching from the tubing.There was no patient consequence reported.

Manufacturer Narrative

(b)(4).Method: one of the complaint unit bc191 bubble cpap flexitrunk was returned to new zealand and where it was visually inspected.The dimensions of the midline cannula housings were also measured and compared against the drawing specifications.Results: the dimensions were all within specifications.Conclusion: no fault was found with the returned bc191 bubble cpap flexitrunk.The user instructions that accompany the flexitrunk infant interface illustrate in pictorial format the correct set-up and proper use of infant interfaces, including the nasal mask and nasal tubing.It also states the following: "connect prongs and mask to nasal tubing ensuring that it is inserted fully." "check that all circuit connections are tight before use and after any adjustment.".

• Brand Name: FLEXITRUNK INFANT NASAL TUBING
• Type of Device: BZO
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8948184
• MDR Text Key: 176060746
• Report Number: 9611451-2019-00829
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC191
• Device Catalogue Number: BC191
• Device Lot Number: 2100712483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Date Manufacturer Received: 09/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1