inforMED
MalfunctionBZO

F&P FLEXITRUNK

Received Jun 30, 2026

Report 9611451-2026-02059 · MDR key 25673160

Device

Generic name

Nasal Tubing

Model number

BC191-05

Catalog number

BC191-05

Product problems

  • Material Split, Cut or Torn

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

(B)(6). FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION. SECTION D4: DEVICE DETAILS WERE NOT PROVIDED. SECTION H4: MANUFACTURING DATE WAS NOT PROVIDED. SECTION G4: PMA/510(K) NUMBER - NO 510(K) NUMBER INCLUDED DUE TO THE SUBJECT DEVICE BEING EXEMPT FROM PMS PATHWAY TO REGULATORY APPROVAL.

Description of Event or Problem

A HEALTHCARE FACILITY IN TEXAS REPORTED THAT THE TUBING OF A BC191-05 FLEXITRUNK NASAL TUBING WAS TORN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.