BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPILONG I

    MDR report key: 1740699 · Received June 17, 2010

    Report

    Report Number
    9611612-2010-00010
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    October 22, 2009
    Report Date
    June 17, 2010
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K060311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR EVALUATION. AT THIS POINT OF TIME NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD AND THE RAW MATERIAL HISTORY FILES FOR THE REPORTED BATCH SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. 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). THIS IS NOT A DEVICE FAILURE BUT A USER ERROR. FINAL USER REPORTED: AFTER PLACING THE CATHETER AND REMOVING THE NEEDLE, AN OCCLUSION WAS NOTICED WHEN INJECTING THE DRUG. THE CATHETER WAS THEN REMOVED AND FOUND WITH A BENT END. NUMBER 3 EPILONG I BELONGING TO LOT NUMBER 789 SHOWED THIS BEHAVIOR. AFTER OUR VISIT TO THE CUSTOMER, WE FOUND OUT: CATHETER WAS NOT PROPERLY FIXED TO THE INJECTION POINT. THE FEEDBACK / COMPLAINT HAS NOT BEEN EVALUATED AS A SEVERE ADVERSE EVENT AND STILL IS NOT. THE (B)(4) MINISTERY OF HEALTH REQUESTED TO FILE A REPORT FOR FORMAL REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPILONG I CAZ 868.5140 ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 041151-602 789

    Patients

    Seq Age Sex Outcome Treatment
    1 Other