BEUDAMED
    FDA Adverse Event Other Summary report: N

    JMS AV FISTULA NEEDLE SET

    MDR report key: 340229 · Received July 2, 2001

    Report

    Report Number
    8031563-2001-00001
    Event Type
    Other
    Date Received
    July 2, 2001
    Date of Event
    May 10, 2001
    Report Date
    June 29, 2001
    Manufacturer
    JMS SINGAPORE PTE. LTD.
    Product Code
    FIE
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    JMS RECEIVED FOLLOWING INFORMATION IN 01/01. - AT TERMINATION OF PT TREATMENT, A RED PLASTIC PIECE WAS FOUND IN THE TUBING OF FISTULA NEEDLE, AND THE SITE WAS CUT IN TWO. FOR THE PRESENT, SAMPLE HAS NOT BEEN RECEIVED YET, BUT IT IS SUPPOSED THAT THE RED PLASTIC MIGHT BE PVC TUBE, WHICH IS USED FOR CONJUNCTION OF PVC TUBE IN PRODUCTION LINE, AND MIGHT BE OVERLOOKED TO ELIMINATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29881 JMS AV FISTULA NEEDLE SET TWIN SET 16GX1/16GX1 BACK EYE W/CLAMP FIE JMS SINGAPORE PTE. LTD. 820-2609 991108511, OR 000509511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other