BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7"(18CM) STANDARD BORE EXTENSION SET WITH REMOVABLE NEUSITE CLEAR NEEDLELESS CON

    MDR report key: 10550748 · Received September 17, 2020

    Report

    Report Number
    1000304305-2020-00004
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Report Date
    August 12, 2020
    Manufacturer
    NP MEDICAL
    Product Code
    FPA
    UDI-DI
    15019517133196
    PMA / PMN Number
    K092382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THREE UNUSED DEVICES THAT WERE RETURNED WERE EVALUATED. THE SAMPLES WERE INSPECTED UNDER MAGNIFICATION. THE WERE NO SIGNS OF LUER CONNECTION WARPAGE OR DEFORMITIES. NO FOREIGN MATERIAL OR GLUE WAS PRESENT. WHEN THE COLLAR WAS PUSHED DOWN TO THE COLLAR STOP, THERE WAS MATERIAL INTERFERENCE THAT MADE THE COLLAR STICK WHEN TRYING TO SLIDE THE COLLAR UPWARDS.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED, PART NUMBER NC5011B- LOT # 19292, DUE TO THE SLIDING COLLAR NOT BEING ABLE TO MOVE. WHEN IT DOES MOVE IT IS STICKY AS IF THERE IS DRIED GLUE OBSTRUCTING THE MOVEMENT OF THE SPINNING COLLAR. THE CONNECTION TO THE CATHETER HUB COULD NOT BE MADE SECURELY ENOUGH TO WITHSTAND A CT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015984 7"(18CM) STANDARD BORE EXTENSION SET WITH REMOVABLE NEUSITE CLEAR NEEDLELESS CON EXTENSION SET FPA NP MEDICAL NC5011B 19292 15019517133196

    Patients

    Seq Age Sex Outcome Treatment
    1