InjuryBSP
SPROTTE® STANDARD
Received Apr 2, 2026 · Event occurred Feb 21, 2026
Report 9611612-2026-00006 · MDR key 24766260
Device
Generic name
Sprotte® Standard
Manufacturer
Pajunk Gmbh MedizintechnologieCatalog number
121151-27A
Lot number
1545
Product problems
- Break
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Description of Event or Problem
(B)(4). INCIDENT OCCURRED IN FRANCE. DURING SPINAL ANESTHESIA FOR A CESAREAN SECTION, THE NEEDLE BROKE JUST BEHIND THE BASE UPON CONTACT WITH A VERTEBRA. THE ANESTHESIOLOGIST REPORTED NO PRIOR DEFORMATION OR TWISTING OF THE NEEDLE. THE BREAK OCCURRED IMMEDIATELY. THE NEEDLE WAS REMOVED AND REPLACED. NO CLINICAL CONSEQUENCES FOR THE PATIENT.
Additional Manufacturer Narrative
THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SEND TO THE AGENCY.