inforMED
MalfunctionBSP

SPROTTE® 2.G

Received Apr 30, 2025 · Event occurred Mar 19, 2025

Report 9611612-2025-00014 · MDR key 21934418

Device

Generic name

Sprotte® 2.g_needle, Conduction, Anesthetic (w/w0 Introducer)

Model number

021251-29A

Catalog number

AA010229

Lot number

1558

Product problems

  • Break
  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

(B)(4). COMPLAINT TOOK PLACE IN ITALY. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

Description of Event or Problem

(B)(4). INCIDENT OCCURRED IN ITALY: DURING THE INSERTION OF THE INTRODUCER, AFTER AN INITIAL DIFFICULTY DUE TO AN OBSTACLE (POSSIBLY A CALCIFIED YELLOW LIGAMENT?), I WAS ABLE TO INSERT THE ENTIRE INTRODUCER WITHOUT DIFFICULTY. HOWEVER, I THEN ENCOUNTERED AN INABILITY TO ADVANCE THE INTRODUCER NEEDLE. UPON REMOVAL OF THE INTRODUCER, I FOUND THAT IT HAD BROKEN.