inforMED
MalfunctionBSP

PLEXOLONG NANOLINE®

Received Jul 7, 2025 · Event occurred Apr 26, 2024

Report 9611612-2025-00025 · MDR key 22412898

Device

Generic name

Plexolong Nanoline®

Catalog number

521156-31A

Lot number

1497

Product problems

  • Break
  • Break

Patient

NA · Unknown

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Additional Manufacturer Narrative

THIS CASE IS REPORTED IN RETROSPECT BASED ON A RE-EVALUATION CONDUCTED IN 2025 FOR FORMAL REASONS. THERE WAS NO PARTICULAR RISK TO PATIENTS, USERS, OR THIRD PARTIES.

Description of Event or Problem

#IRN: (B)(4) INCIDENT OCCURRED IN FRANCE: AN ANAESTHETIST PLACED AN INJECTION CATHETER PREOPERATIVELY FOR ANALGESIA AFTER KNEE PROSTHESIS. THE CATHETER WAS INSERTED WITHOUT ANY PARTICULAR PROBLEM, BUT DURING INJECTION, IT BENT AND BROKE INSIDE THE PATIENT. THE SURGEON IN CHARGE OF THE KNEE REPLACEMENT HAD TO MAKE AN INCISION IN THE PATIENT'S THIGH IN ORDER TO RECOVER THE BROKEN END.