BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX

    MDR report key: 12682821 · Received October 22, 2021

    Report

    Report Number
    3012307300-2021-10178
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 3, 2021
    Report Date
    October 22, 2021
    Product Code
    OJA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PHONE NUMBER (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TPN FLUID WAS STAINING THE PATIENT BED. TPN WAS LEAKING FROM ONE OF THE FILTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581812 MEDEX INFUSION EXTENSION SETS AND DISPOSABLES MEDEX OJA SX720448CZ 4129484

    Patients

    Seq Age Sex Outcome Treatment
    1