BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10550442 · Received September 17, 2020

    Report

    Report Number
    1000304305-2020-00002
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Report Date
    August 12, 2020
    Manufacturer
    NP MEDICAL
    Product Code
    FPA
    UDI-DI
    15019517133202
    PMA / PMN Number
    K092382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RECEIVED TO PERFORM AN AUTOPSY.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED, PART NUMBER NC5011R, WHERE IV ACCESS WAS STARTED AND IV FLUIDS WOULD NOT FLOW TO GRAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016271 7"(18CM) STANDARD BORE EXTENSION SET WITH REMOVABLE NEUSITE CLEAR NEEDLELESS CON EXTENSION SET FPA NP MEDICAL NC5011R 18130 15019517133202

    Patients

    Seq Age Sex Outcome Treatment
    1