BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX

    MDR report key: 12677641 · Received October 21, 2021

    Report

    Report Number
    3012307300-2021-10150
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    August 19, 2021
    Report Date
    October 21, 2021
    Product Code
    OJA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLUE LIPID FILTER ON THE INFUSION SET HAD COME APART AND BLOOD WAS BLEEDING BACK FROM THE BROVIAC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569129 MEDEX INTRAVASCULAR ADMINISTRATION SET OJA SX720448CZ 4165627

    Patients

    Seq Age Sex Outcome Treatment
    1