FISHER AND PAYKEL HEALTHCARE
Received Apr 23, 2026 · Event occurred Mar 30, 2026
Report 9611451-2026-01456 · MDR key 24972396
Device
Generic name
Nasal Cannula
Manufacturer
Fisher & Paykel Healthcare LtdModel number
OPT312Catalog number
OPT312
Lot number
2103979966
Product problems
- Unraveled Material
- Material Split, Cut or Torn
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF AN OPT312 OPTIFLOW JUNIOR NASAL CANNULA WAS TORN DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Additional Manufacturer Narrative
(B)(6). SECTION G4: PMA/510(K) NUMBER - NO 510(K) NUMBER INCLUDED DUE TO THE SUBJECT DEVICE BEING EXEMPT FROM PMS PATHWAY TO REGULATORY APPROVAL. 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.