BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 13471631 · Received February 7, 2022

    Report

    Report Number
    3012307300-2022-02776
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Report Date
    February 7, 2022
    Manufacturer
    NULL
    Product Code
    NQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR INVESTIGATION. IT WAS TESTED FOR FORCE TO ADVANCE AND FORCE TO LOCK WITH NO NON-CONFORMITIES FOUND. THE REPORTED EVENT COULD NOT BE CONFIRMED AS A MANUFACTURING RELATED NONCONFORMANCE. THERE WAS NO FAULT FOUND WITH THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WAS BLUNT WHICH MAKES IT HARD TO PIERCE SKIN WHEN INSERTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993954 JELCO CATHETER, HEMODIALYSIS NQJ 4104092 4104092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown