MalfunctionBSP

SPROTTE®

Received Jul 8, 2025 · Event occurred Jul 18, 2023

Report 9611612-2025-00033 · MDR key 22436796

Device

Generic name

Sprotte®

Manufacturer

Pajunk Gmbh Medizintechnologie

Catalog number

021151-29A

Lot number

1422

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

IRN# (B)(4) INCIDENT OCCURRED IN ITALY. THE NEEDLE BROKE MORE OR LESS IN THE MIDDLE OF THE SHAFT AND ONE PART REMAINED TRAPPED IN THE BACK OF THE PATIENT.