InjuryBSP
SPROTTE®
Received Jul 8, 2025 · Event occurred Nov 29, 2023
Report 9611612-2025-00037 · MDR key 22436795
Device
Generic name
Sprotte®
Manufacturer
Pajunk Gmbh MedizintechnologieCatalog number
121151-30A
Lot number
1312
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 THE UK. PROBLEM WITH THE NEEDLE, WHEREBY THE FIRST 4.5 CM OF THE NEEDLE TIP BROKE (POTENTIALLY OFF THE INTRODUCER, WHILST CAUGHT ON THE TRANSVERSE PROCESS' VERTEBRAE. THE PATIENT HAS A VERY HIGH BMI.