inforMED
InjuryBSP

SPROTTE® 2.G

Received Jul 8, 2025 · Event occurred May 9, 2023

Report 9611612-2025-00036 · MDR key 22436793

Device

Generic name

Sprotte® 2.g

Catalog number

021251-29A

Lot number

1471

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

(B)(4). INCIDENT OCCURRED IN ITALY. DURING THE SPINAL ANESTHESIA PROCEDURE, THE NEEDLE DISTAL PORTION BROKE, ABOUT 3 CM IMMEDIATELY AFTER STARTING THE PROCEDURE.