F&P FlexiTrunk BC192-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 09420012432476), received between Jan 27, 2022 and Feb 27, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (11 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN AUSTRALIA REPORTED THAT THE TUBING OF A BC192-05 FLEXITRUNK NASAL TUBING WAS BROKEN WHEN BEING REMOVED FROM ITS PACKAGING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466047 ↗
• MalfunctionFeb 10, 2026Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE TUBING OF A BC192-05 FLEXITRUNK NASAL TUBING (SUBJECT DEVICE) WAS BROKEN. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE PATIENT EXPERIENCED TWO OXYGEN DESATURATION EVENTS, WITH RECORDED OXYGEN SATURATION LEVELS OF 62% AND 54% SPO2, PRIOR TO THE REPLACEMENT OF THE SUBJECT DEVICE TO CONTINUE THERAPY. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED. FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED ADDITIONAL INFORMATION FROM THE HEALTHCARE FACILITY REGARDING THE REPORTED EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24310812 ↗
• MalfunctionDec 15, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN NETHERLANDS REPORTED THAT THE TUBING OF A BC192-05 FLEXITRUNK NASAL TUBING WAS TORN AND RESULTED IN LEAK DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809553 ↗
• MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A BC192-05 FLEXITRUNK INFANT NASAL TUBING WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306545 ↗
• MalfunctionMar 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A BC192-05 FLEXITRUNK INFANT NASAL TUBING WAS FOUND BROKEN DURING USE ON A PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587578 ↗
• MalfunctionSep 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF A BC192 FLEXITRUNK INFANT NASAL TUBING WAS FOUND CRACKED AFTER ONE DAY OF USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340339 ↗
• MalfunctionJan 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN AUSTRALIA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE BC192 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE TORN CAUSING AIR TO ESCAPE THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540444 ↗
• MalfunctionJan 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN AUSTRALIA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE BC192 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE TORN CAUSING AIR TO ESCAPE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540437 ↗
• MalfunctionOct 26, 2023Gas/Air Leak; Gas/Air Leak

  A HEALTHCARE FACILITY IN AUSTRALIA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A BC192 FLEXITRUNK INFANT NASAL TUBING WAS NOISY AND LEAKING AIR. IT WAS ALSO REPORTED THAT WHEN THEY COVERED THE AREA, LEAKING NOISE REDUCED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18008920 ↗
• MalfunctionJul 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN AUSTRALIA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE BC192 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE TORN BEFORE PATIENT USE. 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 17358002 ↗
• MalfunctionOct 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A DISTRIBUTOR IN INDIA REPORTED VIA A FISHER AND PAYKEL (F&P) HEALTHCARE REPRESENTATIVE, THAT BC192 FLEXITRUNK INFANT NASAL TUBING WAS FOUND BROKEN BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620679 ↗
• MalfunctionJan 27, 2022Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A BC192 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TORN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13376538 ↗