BEUDAMED
    FDA Adverse Event Other Summary report: N

    STIMULONG KIT -TUOHY TIP NEEDLE

    MDR report key: 1352000 · Received February 15, 2006

    Report

    Report Number
    9611612-2006-00008
    Event Type
    Other
    Date Received
    February 15, 2006
    Date of Event
    February 8, 2006
    Report Date
    February 15, 2006
    Manufacturer
    PAJUNK GMBH
    Product Code
    MIA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR WHETHER IT IS A PAJUNK DEVICE OR NOT. PHYSICIAN PROMISED TO SEND DEVICE FOR EVAL. THE REPOSITIONING DONE BY THE ANESTHESIOLOGIST WAS CONTRADICTIVE TO THE OPERATING INSTRUCTIONS OF THE DEVICE. IT IS WRITTEN IN THE OPERATING INSTRUCTIONS: "DO NOT RETRACT THE CATHETER BACK AGAINST THE CUTTING EDGE OF THE CANNULA TIP. THIS MAY CAUSE THE CATHETER TO BE CUT OFF".

    Description of Event or Problem · 1

    DR AT THE HOSP. CALLED TO REPORT AN INCIDENT. ONE CENTIMETER OF THE DISTAL TIP OF A PAJUNK STIMULONG CATHETER WAS CUT OFF IN A FEMALE PT'S NECK -WHILE DOING AN INTERSCALENE BRACHIAL PLEXUS BLOCK FOR A RIGHT SHOULDER ARTHROSCOPY IN 2006. THE ANESTHESIOLOGIST WAS REPOSITIONING THE NEEDLE, THE CATHETER KINKED AND THE TIP OF THE NEEDLE WENT OVER IT AND IT WAS CUT OFF. DR, THE ANESTHESIOLOGIST DOING THE BLOCK CONTACTED A SURGEON AFTER TAKING AN X-RAY OF THE PT AND THE SURGEON, DECIDED TO DO NOTHING. IT WOULD NOT CAUSE ANY HARM. SO, NOTHING ELSE WILL BE DONE. THEY DOCUMENTED THEIR DECISION AND EXPLAINED IT TO THE PT. PT WENT HOME AND IS DOING FINE -NO SENSORY OR MOTOR ISSUES. PHYSICIAN KNEW THIS IS A VERY RARE SITUATION AND INFORMED US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULONG KIT -TUOHY TIP NEEDLE STIMULONG KIT MIA PAJUNK GMBH 531151-32A 601

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other