MalfunctionMOZ
SUPARTZ FX PFS
Received Feb 6, 2020
Report MW5092834 · MDR key 9681885
Device
Generic name
Acid, Hyaluronic, Intraarticular
Manufacturer
Bioventus, LlcProduct problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
SPONTANEOUS CALL FROM MD TO REPORT THAT APPROXIMATELY HALF OF MEDICATION LEAKED OUT OF PRE-FILLED SYRINGE PRIOR TO INJECTION. NO MISSED DOSE, MD USED THEIR OWN SUPPLY. NI ADVERSE EVENT REPORTED. UNKNOWN IF PRODUCTS IS AVAILABLE FOR RETURN. NO OTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.