MalfunctionBSP
SPROTTE® NRFIT SET
Received Jun 24, 2025 · Event occurred Jan 15, 2025
Report 9611612-2025-00019 · MDR key 22319437
Device
Generic name
Sprotte® Nrfit Set_needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Pajunk Gmbh MedizintechnologieModel number
AA010362Catalog number
021166-27A
Lot number
1431
Product problems
- Break
- Break
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IRN# 021-25_947 COMPLAINT TOOK PLACE IN GREAT BRITAIN. 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
IRN # 021-25_947 INCIDENT OCCURRED IN GREAT BRITAIN: AFTER THE SPINAL WAS COMPLETED IT WAS APPARENT WHEN THE SPROTTE WAS REMOVED PART OF THE NEEDLE HAD BROKEN OFF WHICH HAD TO BE REMOVED SURGICALLY.