BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELI QUINCKE POINT SPINAL NEEDLE

    MDR report key: 6499986 · Received April 18, 2017

    Report

    Report Number
    9614709-2017-00001
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Report Date
    March 22, 2017
    Manufacturer
    DR. JAPAN CO., LTD.
    Product Code
    BSP
    UDI-DI
    00386120006758
    PMA / PMN Number
    K990519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE STYLET OF THE NEEDLE IS STICKING; BEING DIFFICULT TO REMOVE FROM THE NEEDLE HUB WITH THE USE OF ONE HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284381 RELI QUINCKE POINT SPINAL NEEDLE SPINAL NEEDLE BSP DR. JAPAN CO., LTD. SN22G351 60201AV 00386120006758

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown