SPROTTE® 2.G
Received Jul 2, 2025 · Event occurred Feb 5, 2025
Report 9611612-2025-00022 · MDR key 22381699
Device
Generic name
Sprotte® 2.g_needle, Conduction, Anesthetic (w/w0 Introducer)
Manufacturer
Pajunk Gmbh MedizintechnologieModel number
041251-29ACatalog number
041251-29A
Lot number
1541
Product problems
- Break
- Break
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IRN#(B)(4). COMPLAINT TOOK PLACE IN ITALY. THIS INCIDENT WAS CLASSIFIED AS CO-REPORTED FOR USA ON 07-02-2025 AFTER REASSESSMENT. 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# (B)(4). INCIDENT OCCURRED IN ITALY: WHILE REMOVING THE NEEDLE TO CHANGE POSITION, IT BROKE AND THE STUMP REMAINED INSIDE THE PATIENT, IMPOSSIBLE TO REMOVE WITH BARE HANDS (ABOUT 4.5CM). THEREFORE, THE PATIENT REQUIRED A DIAGNOSTIC-THERAPEUTIC PATHWAY, WHICH ENDED WITH THE REMOVAL OF THE STUMP BY THE NEUROSURGERY COLLEAGUES. NO NEUROLOGICAL DAMAGE WAS REPORTED IN THE PATIENT THROUGHOUT THE PERIPROCEDURAL PATHWAY.
Additional Manufacturer Narrative
(B)(4). COMPLAINT TOOK PLACE IN ITALY. G1 CORRECTION: INSERT EMAIL ADRESS. THIS INCIDENT WAS CLASSIFIED AS CO-REPORTED FOR USA ON 07-02-2025 AFTER REASSESSMENT. 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# (B)(4). INCIDENT OCCURRED IN ITALY: WHILE REMOVING THE NEEDLE TO CHANGE POSITION, IT BROKE AND THE STUMP REMAINED INSIDE THE PATIENT, IMPOSSIBLE TO REMOVE WITH BARE HANDS (ABOUT 4.5CM). THEREFORE, THE PATIENT REQUIRED A DIAGNOSTIC-THERAPEUTIC PATHWAY, WHICH ENDED WITH THE REMOVAL OF THE STUMP BY THE NEUROSURGERY COLLEAGUES. NO NEUROLOGICAL DAMAGE WAS REPORTED IN THE PATIENT THROUGHOUT THE PERIPROCEDURAL PATHWAY.