BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPROTTE 2.G

    MDR report key: 7976641 · Received October 18, 2018

    Report

    Report Number
    9611612-2018-00039
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    January 1, 2018
    Report Date
    October 18, 2018
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    14048223024307
    PMA / PMN Number
    K911202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON RISK MANAGEMENT EVALUATION AND CLINICAL EVALUATION THIS FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). TENTATIVE TRANSLATION, SUMMARIZING, FROM INITIAL REPORTER´S NARRATIVE: CANNULA IS BROKEN OFF AT THE TRANSPARENT HUB. CANNULA STILL PROTRUDED 2 MM OUT OF PATIENT'S BACK. THE CANNULA COULD BE PULLED OUT OF THE PATIENT WITH A STERILE CLAMP. PATIENT LAY IN LATERAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822250 SPROTTE 2.G ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 021251-29A 1219 14048223024307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other