F&P OPTIPAP JUNIOR
Received Jun 25, 2026
Report 9611451-2026-02017 · MDR key 25631329
Device
Generic name
Nasal Tubing
Manufacturer
Fisher & Paykel Healthcare LtdModel number
OPTIPAPFCatalog number
OPTIPAPF
Product problems
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). 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 & H4: DEVICE DETAILS WERE NOT PROVIDED. SECTION G4: THE OPTIPAPF JUNIOR FLEXITUBE IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K250651.
Description of Event or Problem
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT DURING AN INTERFACE CHANGE, A NURSE PULLED ON THE TUBE OF OPTIPAPF JUNIOR FLEXITUBE AGGRESSIVELY CAUSING IT TO BREAK. THERE WAS NO REPORTED PATIENT CONSEQUENCE.