BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPROTTE® NRFIT SET

    MDR report key: 22319437 · Received June 24, 2025

    Report

    Report Number
    9611612-2025-00019
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    January 15, 2025
    Report Date
    June 24, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    PMA / PMN Number
    K241953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IRN# 021-25_947 COMPLAINT TOOK PLACE IN GREAT BRITAIN. 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 · 0

    IRN # 021-25_947 INCIDENT OCCURRED IN GREAT BRITAIN: AFTER THE SPINAL WAS COMPLETED IT WAS APPARENT WHEN THE SPROTTE WAS REMOVED PART OF THE NEEDLE HAD BROKEN OFF WHICH HAD TO BE REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972361 SPROTTE® NRFIT SET SPROTTE® NRFIT SET_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP PAJUNK GMBH MEDIZINTECHNOLOGIE AA010362 1431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other