BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPROTTE® LUMBAR

    MDR report key: 23109510 · Received September 22, 2025

    Report

    Report Number
    9611612-2025-00043
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 7, 2025
    Report Date
    November 20, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    04048223108611
    PMA / PMN Number
    K250774
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IRN # (B)(4) INCIDENT OCCURRED IN SWITZERLAND. AFTER THE INITIAL REPORTER SUBMITTED THE UPDATE FROM THE SWISS MEDIC REPORT, THE INITIAL REPORTER CHANGED IN THE REPORT AND THE CODES UNDER H6. FURTHERMORE, THE DATE OF AWARENESS WAS ADDED TO THE REPORT. THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SENT TO THE AGENCY.

    Additional Manufacturer Narrative · 0

    IRN#(B)(4). INCIDENT OCCURRED IN SWITZERLAND. THE FINAL RESULTS WILL BE SENT TO AGENCY AFTER INVESTIGATION OF AFFECTED DEVICE.

    Description of Event or Problem · 0

    IRN# (B)(4) INCIDENT OCCURED IN SWITZERLAND. ON (B)(6) 2025: SPROTTE LUMBAR IS BROKEN OFF ON (B)(6) 2025: UPDATE OF EVENT PROBLEM: PERFORMING A LUMBAR PUNCTURE ON A PATIENT WITH DEMENTIA (A.E. LEWY BODY).INDICATION: DETERMINATION OF DEMENTIA MARKERS. PATIENT IN LEFT LATERAL POSITION, AFTER MARKING THE PUNCTURE SITE AT THE LEVEL OF THE UPPER EDGE OF THE OS ILII, DISINFECTION AND STERILE DRAPING. THE ASSISTANT DOCTOR THEN INSERTS THE SPACER NEEDLE BETWEEN THE SPINOUS PROCESSES. AFTER A SLIGHT READJUSTMENT DUE TO RESISTANCE, THE NEEDLE CAN BE INSERTED AS FAR AS IT WILL GO. THREE UNSUCCESSFUL ATTEMPTS ARE MADE TO PUNCTURE WITH THE PUNCTURE NEEDLE THROUGH THE SPACER, WITH THE USUAL READJUSTMENT AFTER EACH ATTEMPT (THE SPACER REMAINS IN SITU THROUGHOUT). THEN THERE IS A CHANGE OF HANDS; THE PUNCTURE NEEDLE IS COMPLETELY WITHDRAWN FOR THIS PURPOSE, WHILE THE SPACER REMAINS IN SITU. WHEN REINSERTING THE NEEDLE THROUGH THE SPACER, THERE IS RESISTANCE; THE NEEDLE SEEMS TO RUB SLIGHTLY AGAINST THE SPACER. WITH A LITTLE MORE PRESSURE FROM THE PUNCTURE HAND, HOLDING THE BACK OF THE NEEDLE, THE RESISTANCE CAN BE OVERCOME AND 2-3 FURTHER UNSUCCESSFUL PUNCTURE ATTEMPTS ARE MADE. A DECISION IS THEN MADE TO REPOSITION THE SPACER. THE NEEDLE IS REMOVED WITH LITTLE RESISTANCE. WHEN THE SPACER HOLDER IS REMOVED, ONLY THE PLASTIC PART COMES AWAY FROM THE PATIENT, BUT NOT THE CANNULA. THIS HAS FALLEN OUT OF THE PLASTIC HOLDER, BUT IS NOT BROKEN. IT MUST BE RETRIEVED THE FOLLOWING DAY IN THE OPERATING THEATRE UNDER BV CONTROL. THE NEEDLE ITSELF DID NOT CAUSE ANY SERIOUS INJURIES OR CONSEQUENCES,AND INTRAOPERATIVE REMOVAL UNDER BV CONTROL WAS CARRIED OUT WITHOUT ANY PROBLEMS. THE PATIENT UNDERWENT UNNECESSARY GENERAL ANAESTHESIA,WHICH IS NOT CONDUCIVE TO THE FURTHER DEVELOPMENT OF DEMENTIA OR RECOVERY OF MENTAL HEALTH.

    Description of Event or Problem · 0

    IRN#(B)(4). INCIDENT OCCURED IN SWITZERLAND. SPROTTE LUMBAR IS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701407 SPROTTE® LUMBAR SPROTTE® LUMBAR 21G X 90MM BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 1557 04048223108611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other