BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXOLONG NANOLINE MEIER

    MDR report key: 3063100 · Received April 11, 2013

    Report

    Report Number
    9611612-2013-00005
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 11, 2013
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K013041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD AND RELEVANT RAW MATERIAL HISTORY FILES DID NOT INDICATE RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. ANY FURTHER INFORMATION WILL BE SENT IN TO FDA AS SOON AS IT BECOMES AVAILABLE. IF NO FURTHER INFORMATION BECOMES AVAILABLE, PAJUNK CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED TO (B)(6). FROM USER'S/INITIAL REPORTER'S NARRATIVE: "DURING A CONTINUOUS BLOCK, CATHETER HAS STOPPED INSIDE THE NEEDLE AND THE USER COULDN'T MOVE THE CATHETER NEITHER BACKWARD NOR FORWARD. SO THE USER HAD TO REMOVE THE NEEDLE ITSELF WITH CATHETER INSIDE AND HE DIDN'T MAKE THE CONTINUOUS BLOCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156958 PLEXOLONG NANOLINE MEIER 868.5150 ANESTHESIA CONDUCTION NEEDLE CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 531156-31A 993

    Patients

    Seq Age Sex Outcome Treatment
    1 Other