F&P FlexiTrunk BC190-05Recalls & reported problems
Fisher & Paykel Healthcare Limited · Nasal Tubing · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Fisher & Paykel FlexiTrunk nasal tubing is used with ventilators. The 25 reports mostly describe the tubing splitting, tearing or breaking, sometimes with air leaks; most mention no patient involvement or symptoms. There were no deaths or injuries, and 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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 09420012432452), received between Jun 2, 2020 and Sep 1, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (18 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 Torn18
- Break7
- Gas/Air Leak3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Low Oxygen Saturation2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554041 ↗MalfunctionApr 22, 2026Gas/Air Leak; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A BC190-05 FLEXITRUNK NASAL TUBING WAS BROKEN AND RESULTED IN LEAK DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24952074 ↗MalfunctionApr 2, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN BELGIUM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE 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 24764544 ↗MalfunctionJan 15, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN NEW YORK REPORTED VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE TUBING OF A BC190-05 NASAL TUBING WAS TORN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24090258 ↗MalfunctionNov 25, 2025Break; Break
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE 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 23652779 ↗MalfunctionSep 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF A BC190-05 FLEXITRUNK INFANT NASAL TUBING WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974926 ↗MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN OHIO REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND BROKEN. 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 21602143 ↗MalfunctionDec 3, 2024Break; Break
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY HAS REPORTED THAT THE BC190-05 NASAL TUBING 50MM'S TUBING WAS TORN WHILE TAKEN OUT OF THE BOX. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20839686 ↗MalfunctionOct 23, 2024Break; Gas/Air Leak; Break; Gas/Air Leak
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE BC190-05, NASAL TUBING 50MM WAS LEAKING AIR. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20513061 ↗MalfunctionOct 20, 2024Break; Break
A HEALTHCARE FACILITY IN CINCINNATI REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE BC190-05 NASAL TUBING 50MM'S TUBING HAD A CRACK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20490389 ↗MalfunctionOct 8, 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 BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND DAMAGED 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 20403769 ↗MalfunctionJul 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN OHIO REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING HAD A HOLE IN THE TUBING. 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 19662274 ↗MalfunctionDec 5, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18264444 ↗MalfunctionOct 18, 2023Break; Break
A HEALTHCARE FACILITY IN CHINA REPORTED VIA A NMPA REPORTING SYSTEM THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE BROKEN 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 17962421 ↗MalfunctionAug 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY, THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS CRACKED. 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 17455996 ↗MalfunctionDec 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY, THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE DAMAGED AFTER PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15921348 ↗MalfunctionDec 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE DAMAGED WHEN TAKEN OUT OF ITS PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15920659 ↗MalfunctionOct 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE DAMAGED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15664288 ↗MalfunctionMay 30, 2022Detachment of Device or Device Component
A HEALTHCARE FACILITY IN FLORIDA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING DETACHED FROM THE MASK. THE PATIENT EXPERIENCED OXYGEN DESATURATION BUT RECOVERED TO A STABLE CONDITION. THE HEALTHCARE FACILITY ALSO REPORTED TWO OTHER PATIENT EVENTS THAT HAVE BEEN REPORTED SEPARATELY. NO FURTHER PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions
MAUDE report 14545153 ↗MalfunctionMay 12, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE DAMAGED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14386275 ↗MalfunctionAug 18, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12340374 ↗MalfunctionJun 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY, THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE DAMAGED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980872 ↗MalfunctionMar 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND TO BE DAMAGED DURING USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11446728 ↗MalfunctionMar 3, 2021Gas/Air Leak; Gas/Air Leak
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11408139 ↗MalfunctionFeb 2, 2021Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE BC190 FLEXITRUNK INFANT NASAL TUBING WAS FOUND DAMAGED. IT WAS REPORTED THAT THE PATIENT DESATURATED FOR A SHORT TIME BUT THERE WAS NO ADVERSE EFFECT. THE PATIENT IS IN A STABLE CONDITION.
Patient problems: Low Oxygen Saturation
MAUDE report 11267569 ↗
Other Set, Tubing And Support, Ventilator (W Harness) devices
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- F&P FlexiTrunk BC191-05Fisher & Paykel Healthcare Limited · Set, Tubing And Support, Ventilator (W Harness)76 reports
- 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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