MAUDE Adverse Event Report: FLEXITRUNK INFANT NASAL TUBING; BZO

Model Number	BC190
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint bc190 flexitrunk infant nasal tubing was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information, videograph and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the videograph and photograph confirmed the reported event, however the location and cause of the leak is unclear.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All flexitrunk infant nasal tubings are visually inspected and pressure tested during production and those that fail are rejected.This suggests that the damage on the subject nasal tubing occurred after it was released for distribution.Our user instructions that accompany the flexitrunk infant nasal tubing state: "use caution when positioning 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." a caution insert is included in the packaging to remind the user to take extra care when handling the flexitrunk.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher & paykel healthcare (f&p) field representative that a bc190 flexitrunk infant nasal tubing was found leaking air.There was no patient involvement.

• Brand Name: FLEXITRUNK INFANT NASAL TUBING
• Common Device Name: BZO
• MDR Report Key: 11408139
• Report Number: 9611451-2021-00244
• Device Sequence Number: 16987313
• Product Code: BZO
• UDI-Device Identifier: 09420012413390
• UDI-Public: 010942001241339010
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BC190
• Device Catalogue Number: BC190
• Device Lot Number: 2101194220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1