BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPROTTE®

    MDR report key: 21887853 · Received April 23, 2025

    Report

    Report Number
    9611612-2025-00010
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 23, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    04048223116753
    PMA / PMN Number
    K911202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IRN# (B)(4). COMPLAINT TOOK PLACE IN SWEDEN. THIS INCIDENT DID NOT TAKE PLACE IN THE USA, BUT AS CO-REPORTED. 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# (B)(4). INCIDENT OCCURRED IN SWEDEN: THE NEEDLE CAME OFF/DISCONNECTED FROM THE CANNULA HOLDER, SEE ATTACHED PICTURE. THE NEEDLE REMAINED IN THE PATIENT, BARELY 1 CM OF THE NEEDLE WAS VISIBLE AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679477 SPROTTE® SPROTTE®_NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 511151-29A 1527 04048223116753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other