BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOPLEX® II

    MDR report key: 23521676 · Received November 11, 2025

    Report

    Report Number
    9611612-2025-00046
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 20, 2025
    Report Date
    December 23, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    04048223131008
    PMA / PMN Number
    K243682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IRN#(B)(4). FU 12/23/2025: THE DEVICE WAS EVALUATED AND THE INVESTIGATION RESULTS DESCRIBED AND THE IMDRF CODES UPDATED. FURTHERMORE, THE UDI WAS UPDATED. 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) INVESTIGATION IS ONGOING. FINAL EVALUATION CAN BE FOUND IN FOLLOWING REPORT.

    Description of Event or Problem · 0

    IRN# (B)(4). INCIDENT OCCURRED IN BELGIUM. TENTITIVE TRANSLATION: WHILE REPOSITIONING THE NEEDLE DURING LOCAL ANESTHESIA, THE NEEDLE BROKE OFF INSIDE THE PATIENT; FORTUNATELY, A SMALL PIECE WAS VISIBLE AND THE DOCTOR WAS ABLE TO REMOVE THE NEEDLE COMPLETELY.

    Description of Event or Problem · 0

    IRN# (B)(4) INCIDENT OCCURRED IN BELGIUM. TENTITIVE TRANSLATION: WHILE REPOSITIONING THE NEEDLE DURING LOCAL ANESTHESIA, THE NEEDLE BROKE OFF INSIDE THE PATIENT; FORTUNATELY, A SMALL PIECE WAS VISIBLE AND THE DOCTOR WAS ABLE TO REMOVE THE NEEDLE COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2542087 SONOPLEX® II SONOPLEX® II BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 1585 04048223131008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other