BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 11751193 · Received April 30, 2021

    Report

    Report Number
    3012307300-2021-03631
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 30, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    UDI-DI
    40695085401002
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A LEVEL 1 HOTLINE ACCESSORY. IT WAS REPORTED THAT THE IV LINE WITH FILTER FOR HHT PATIENT WAS LEAKING AT THE FILTER SITE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652044 LEVEL 1 LGZ SMITHS MEDICAL ASD, INC. L-10 40695085401002

    Patients

    Seq Age Sex Outcome Treatment
    1