F&P FlexiTrunk BC191-05Recalls & reported problems
Fisher & Paykel Healthcare Limited · Nasal Tubing · Class 1
Quick summary
This Fisher & Paykel FlexiTrunk nasal tubing set connects a ventilator's breathing support harness to a patient's nose. Most of the 74 reports describe the tubing tearing, splitting or breaking during use, sometimes with pinhole leaks or air escaping, and a few mention parts coming loose or fluid leaking. No deaths or injuries are reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 76
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 09420012432469), received between Dec 12, 2018 and Sep 29, 2026 — classified as 76 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (44 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn44
- Break21
- Gas/Air Leak13
- Detachment of Device or Device Component4
- Fluid/Blood Leak3
- Device Damaged Prior to Use1
- Leak/Splash1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions74
- Low Oxygen Saturation2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938900 ↗MalfunctionSep 21, 2026Gas/Air Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849337 ↗MalfunctionAug 27, 2026Gas/Air Leak; Material Split, Cut or Torn
A healthcare facility in (b)(6) reported that the a BC191-05 FlexiTrunk Nasal Tubing torn during use. It was further reported that the device was replaced. There were no reported patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50467019 ↗MalfunctionJul 5, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CALIFORNIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF SIX BC191-05 FLEXITRUNK NASAL TUBING WERE FAILING DUE TO PINHOLE LEAKS OR TEARS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25713113 ↗MalfunctionMay 26, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25295606 ↗MalfunctionMay 15, 2026Break
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179881 ↗MalfunctionMay 1, 2026Break
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A BC191- 05 FLEXITRUNK NASAL TUBING WAS FOUND BROKEN BEFORE BEING USED ON A PATIENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25053997 ↗MalfunctionApr 21, 2026Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948334 ↗MalfunctionApr 2, 2026Fluid/Blood Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE BC191-05 FLEXITRUNK NASAL TUBING WAS LEAKING DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24764823 ↗MalfunctionApr 1, 2026Gas/Air Leak
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A LEAK WAS IDENTIFIED WHILE USING A BC191-05 FLEXITRUNK NASAL TUBING. IT WAS FURTHER REPORTED THAT TWO OTHER UNITS WERE AFFECTED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761328 ↗MalfunctionApr 1, 2026Leak/Splash; Gas/Air Leak
A HEALTHCARE FACILITY IN (B)(6) HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A BC191-05 FLEXITRUNK NASAL TUBING WAS FOUND LEAKING AT THE CONNECTOR. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754294 ↗MalfunctionMar 31, 2026Gas/Air Leak
A HEALTHCARE FACILITY IN WEST VIRGINIA HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE A BC191-05 FLEXITRUNK NASAL TUBING WAS FOUND LEAKING AT THE CONNECTOR. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750338 ↗MalfunctionMar 20, 2026Gas/Air Leak
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE BC191-05 FLEXITRUNK NASAL TUBING WAS OBSERVED TO BE LEAKING. IT WAS FURTHER REPORTED THAT FIVE UNITS WERE AFFECTED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646634 ↗MalfunctionMar 6, 2026Material Split, Cut or Torn
A DISTRIBUTOR IN BRAZIL REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN BC191-05 FLEXITRUNK NASAL TUBING WAS FOUND TO BE BROKEN, RESULTING IN AN AIR LEAK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528643 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
WHILE PREPARING TO PLACE THE PT ON NASAL CPAP THE CIRCUIT WOULD NOT PASS LEAK TEST FOR CIRCUIT CALIBRATION. THE PROBLEM WAS DETERMINED TO BE THE TRUNK. WE USED TWO 70 MM TRUNKS THAT BOTH FAILED LEAK TESTING. USED A THIRD 70 MM TRUNK FROM A DIFFERENT LOT NUMBER AND THE LEAK TEST FINALLY PASSED. BOTH FAILED TRUNKS WERE FROM LOT 2103966750. HEALTH EFFECT CODE: 4582. DEVICE PROBLEM CODE: 1250. REFERENCE REPORT: MW5184622.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498476 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
WHILE PREPARING TO PLACE THE PATIENT ON NASAL CPAP THE CIRCUIT WOULD NOT PASS LEAK TEST FOR CIRCUIT CALIBRATION. THE PROBLEM WAS DETERMINED TO BE THE TRUNK. WE USED TWO 70 MM TRUNKS THAT BOTH FAILED LEAK TESTING. USED A THIRD 70 MM TRUNK FROM A DIFFERENT LOT NUMBER AND THE LEAK TEST FINALLY PASSED. BOTH FAILED TRUNKS WERE FROM LOT 2103966750. HEALTH EFFECT CODE: 4582. DEVICE PROBLEM CODE: 1250. REFERENCE REPORT: MW5184623.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498440 ↗MalfunctionFeb 2, 2026Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS CRACKED DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24242854 ↗MalfunctionJan 12, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS DAMAGED BEFORE BEING USED ON A PATIENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24049917 ↗MalfunctionDec 17, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS TORN AND RESULTED IN A LEAK DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835437 ↗MalfunctionDec 16, 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 BC191-05 FLEXITRUNK NASAL TUBING WAS BROKEN BEFORE USE ON A PATIENT. THE HEALTHCARE FACILITY HAS FURTHER REPORTED THAT THE DEVICE WAS IMMEDIATELY REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824177 ↗MalfunctionDec 3, 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 BC191-05 FLEXITRUNK NASAL TUBING WAS TORN BEFORE BEING USED ON A PATIENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707232 ↗MalfunctionNov 27, 2025Break; Break
A HEALTHCARE FACILITY IN CHINA REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE BLUE HOOK LINE (GLIDER) OF A BC190-05 FLEXITRUNK NASAL TUBING 50MM WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23667658 ↗MalfunctionNov 19, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED VIA FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING 70MM WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23600767 ↗MalfunctionNov 16, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN TAIWAN REPORTED THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23565702 ↗MalfunctionOct 21, 2025Break; Break
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF A BC191- 05 FLEXITRUNK NASAL TUBING WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23354311 ↗
Other Set, Tubing And Support, Ventilator (W Harness) devices
- Breathing circuit set, coaxial 260128Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)2 recalls10 reports
- Percussionaire P5-TEEPercussionaire Corporation · Set, Tubing And Support, Ventilator (W Harness)2 recalls1 report
- HUDSON RCI IPN043837Teleflex Incorporated · SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)1 recall18 reports
- Breathing circuit set, coaxial 260127Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)1 recall7 reports
- Breathing circuit set, coaxial 260168Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)1 recall4 reports
- Breathing circuit set, coaxial 260167Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)1 recall3 reports
- HUDSON RCI IPN044039Teleflex Incorporated · SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)1 recall0 reports
- INOmax 91346Mallinckrodt Manufacturing LLC · Set, Tubing And Support, Ventilator (W Harness)1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.