HIGH FLOW NASAL CANNULA INTERMEDIATE INFANT MAXIMUM 8 LPM
Received Feb 18, 2026 · Event occurred Jan 19, 2026
Report 3006061749-2026-00004 · MDR key 24374943
Device
Generic name
High Flow Nasal Cannula
Manufacturer
Flexicare Medical LtdModel number
NACatalog number
032-13-151U, 032-13-152U
Lot number
250601230, 240602355, 24090216
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CANNULAS ARE FALLING APART DURING USE; SEEING ISSUES AT 8LPM AND 15LPM. NO REPORT OF SERIOUS INJURY/HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION; INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE-THREATENING. NO REPORT OF DEATH.
Additional Manufacturer Narrative
SCAR-149 - SCAR RAISED - AWAITING RESULTS OF INVESTIGATION. DEVICE HAS BEEN SHIPPED TO MANUFACTURING SITE FOR INVESTIGATION.
Description of Event or Problem
CANNULAS ARE FALLING APART DURING USE. SEEING ISSUES AT 8 LPM AND 15 LPM. NO REPORT OF SERIOUS INJURY/HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE-THREATENING. NO REPORT OF DEATH.
Description of Event or Problem
CANNULAS ARE FALLING APART DURING USE. SEEING ISSUES AT 8 LPM AND 15 LPM. NO REPORT OF SERIOUS INJURY/HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE-THREATENING. NO REPORT OF DEATH.
Additional Manufacturer Narrative
SCAR-149 - SCAR RAISED - AWAITING RESULTS OF INVESTIGATION. DEVICE HAS BEEN SHIPPED TO MANUFACTURING SITE FOR INVESTIGATION.
Description of Event or Problem
CANNULAS ARE FALLING APART DURING USE. SEEING ISSUES AT 8LPM AND 15LPM. NO REPORT OF SERIOUS INJURY/HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE-THREATENING. NO REPORT OF DEATH.
Remedial action
- Inspection