BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONOPLEX STIM

    MDR report key: 2253135 · Received August 23, 2011

    Report

    Report Number
    9611612-2011-00055
    Event Type
    Other
    Date Received
    August 23, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 5, 2011
    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 HISTORY RECORD AND RELEVANT RAW MATERIAL HISTORY FILES OF THE REPORTED BATCH DID NOT INDICATE RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. ANY FURTHER INFO WILL BE SENT IN TO FDA AS SOON AS IT BECOMES AVAILABLE. IF NO FURTHER INFO BECOMES AVAILABLE PAJUNK CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). EVENT TOOK PLACE IN (B)(6). USERS NARRATIVE: WHILST PERFORMING A FEMORAL NERVE BLOCK WITH A 22G, 50 MM PAJUNK NEEDLE, THE NEEDLE SNAPPED OFF FROM THE PLASTIC HUB WITH A CLEAN BREAK, AND WAS LOST DEEP IN THE PTS SUB-CUTANEOUS TISSUES. THE ABOVE WAS WITNESSED BY THE SURGEON AND THE ODP, AND NO UNDUE FORCES WERE APPLIED TO CAUSE THIS, ALTHOUGH THE PT WAS OBESE, AND THE BLOCK WOULD HAVE BEEN QUITE DIFFICULT. SURGEON USING X-RAY CONTROL MADE A 1-1.5 CM INCISION IN THE GROIN AND WAS ABLE TO FULLY REMOVE THE BROKEN 50 MM NEEDLE INTACT. IT WAS BENT AT 90 DEGREES DUE TO THE SURGICAL REMOVAL. ON INSPECTION ANOTHER UNOPENED NEEDLE OF THE SAME BATCH LOT 920, WAS FOUND TO BE BROKEN OFF IN THE PACKET AND THIS BATCH WAS IMMEDIATELY REMOVED AND THE REP INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONOPLEX STIM 868.5150 ANESTHESIA CONDUCTION NEEDLE. BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 001185-74 920

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention