F&P FlexiTrunk BC802-10Recalls & reported problems

Fisher & Paykel Healthcare Limited · Infant Nasal Mask · Class 1

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09420012432698), received between May 26, 2024 and Apr 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Gas/Air Leak1
Material Split, Cut or Torn1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 6, 2025Gas/Air Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN OHIO HAS REPORTED THAT A BC802-10 INFANT NASAL MASK MEDIUM BCPAP COULD NOT HOLD A SEAL AND LEAKS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21782726 ↗
MalfunctionMay 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN AUSTRALIA REPORTED THAT A BC802 INFANT NASAL MASK WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19399233 ↗

Device details

UDI-DI	`09420012432698`
Brand	F&P FlexiTrunk
Model	BC802-10
Company	Fisher & Paykel Healthcare Limited
Product code	BYG · Mask, Oxygen
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 10, 2026

Device type (GMDN): CPAP/BPAP nasal mask, single-use

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.