BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONOPLEX NANOLINE CANNULA

    MDR report key: 1951136 · Received December 22, 2010

    Report

    Report Number
    9611612-2010-00043
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    December 8, 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
    PHYSICIAN

    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 THE RELEVANT RAW MATERIAL HISTORY FILES INDICATED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. IF NO FURTHER INFO BECOMES AVAILABLE AND IN CASE NO CORRECTIVE/PREVENTIVE ACTION IS INDICATED, 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) AUTHORITIES. UNCLEAR WHAT HAPPENED. INVESTIGATION RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONOPLEX NANOLINE CANNULA 868.5150 ANESTHESIA CONDUCTION NEEDLE BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 001185-74

    Patients

    Seq Age Sex Outcome Treatment
    1 Other