BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOPLEX NANOLINE CANNULA

    MDR report key: 1950956 · Received December 22, 2010

    Report

    Report Number
    9611612-2010-00038
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 22, 2010
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    PMA / PMN Number
    K000722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    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 MASTER RECORD AND RELEVANT RAW MATERIAL HISTORY FILES SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. THE INCIDENT INDICATES TO BE LOCALLY ISOLATED IN (B)(6), POSSIBLY DUE TO TRANSPORTATION/ STORAGE FAILURE. INVESTIGATION IS STILL RUNNING. A 100%-LEAKAGE-TIGHTNESS TEST HAS BEEN IMPLEMENTED IN CLEANROOM. REPRESENTATIVE SAMPLES ARE INSPECTED FOR LEAK TIGHTNESS AFTER STERILIZATION. IF NO FURTHER INFORMATION BECOMES AVAILABLE AND IN CASE NO CORRECTIVE/PREVENTIVE ACTION IS INDICATED PAJUNK CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    (B)(6). USER'S NARRATIVE: "LEAK AT THE BASE OF THE NEEDLE". TWO DIFFERENT ITEMS FROM 2 DIFFERENT LOTS AFFECTED. LEAKAGE AT HUB NOTICED PRIOR TO USE. DEVICE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONOPLEX NANOLINE CANNULA 868.5150 ANESTHESIA CONDUCTION NEEDLE BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 001156-71 874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other