InjuryBSP
SPROTTE® 2.G
Received Jul 8, 2025 · Event occurred Nov 10, 2023
Report 9611612-2025-00030 · MDR key 22436775
Device
Generic name
Sprotte® 2.g
Manufacturer
Pajunk Gmbh MedizintechnologieCatalog number
121251-27A
Lot number
1259
Product problems
- Break
- Break
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
IRN# (B)(4) INCIDENT OCCURRED IN (B)(6). THE PATIENT IS IN LABOUR AND OPEN 9 CM AND ABOUT TO GET SPINAL ANESTHESIA. AT THE FIRST ATTEMPT THERE IS NO BACK SUCTION, AND WE TRY TO ADJUST BY PULLING THE NEEDLE OUT SLOWLY. A FAINT RESISTANCE AFTER ABOUT 5 MM AND THEN THE NEEDLE BREAKS IN TWO ABOUT 1 CM FROM THE INTRODUCER.
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.