BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELI QUINCKE POINT SPINAL NEEDLE

    MDR report key: 6001936 · Received October 5, 2016

    Report

    Report Number
    9614709-2016-00001
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    August 26, 2016
    Report Date
    August 30, 2016
    Manufacturer
    DR. JAPAN CO., LTD.
    Product Code
    BSP
    PMA / PMN Number
    K990519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE STYLET (WIRE) WAS DIFFICULT TO REMOVE FROM NEEDLE HUB DURING A CERVICAL TRANSFORAMINAL LUMBAR BLOCK PROCEDURE. THE CLINICIAN STATED THE EXTRA FORCE NEEDED TO REMOVE THE STYLET FROM THE NEEDLE HUB MADE THE NEEDLE DIFFICULT TO CONTROL. NO HARM CAME TO THE PATIENT AND THERE WERE NO ADVERSE EFFECTS REPORTED AS PART OF THE COMPLAINANT FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653447 RELI QUINCKE POINT SPINAL NEEDLE SPINAL NEEDLE BSP DR. JAPAN CO., LTD. 60101AF

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown