inforMED
MalfunctionMOZ

DUROLANE PREFILLED SYRINGE

Received Dec 12, 2023 · Event occurred Dec 11, 2023

Report MW5149189 · MDR key 18319262

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc.

Lot number

21083

Patient

53 YR · Male

  • Needle Stick/Puncture
  • Needle Stick/Puncture

Narrative

Description of Event or Problem

SPONTANEOUS. RN REPORTED THAT DUROLANE PRODUCT RECEIVED WAS DEFECTIVE. THE NEEDLE WAS NOT THREADED CORRECTLY TO THE PFS(PREFILLED SYRINGE) AND WHEN MD ADMINISTERED THE MEDICATION, THE PRODUCT SPILLED OUT OVER THE TOP OF THE SYRINGE RATHER THAN INJECTED INTO THE PATIENT'S KNEE. MD USED THEIR OWN STOCK TO PREVENT MISSED DOSE DATE OF DOSE AND DATE OF MALFUNCTION: 12/11/2023. NO MISSED DOSE OR ADVERSE EVENT REPORTED. UNKNOWN IF DEFECTIVE DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.