BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX

    MDR report key: 12425512 · Received September 3, 2021

    Report

    Report Number
    3012307300-2021-09157
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    July 19, 2021
    Report Date
    November 12, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    OJA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE UNUSED UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD NOT BE DUPLICATED AND THE DEVICE PASSED ALL FUNCTIONAL TESTS. DHR REVIEW WAS DONE, NO ISSUES RELATED TO THE ORIGINAL COMPLAINT WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TPN FILTER WAS FOUND TO BE LEAKING. THE BLUE ASPECT OF THE TPN FILTER WAS EXAMINED AND HAD BLOOD INSIDE IT, EITHER THE LINE HAD BLED BACK OR THE FILTER HAD FRACTURED. NO LIPID WAS BEING DELIVERED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317230 MEDEX INTRAVASCULAR ADMINISTRATION SET. OJA SMITHS MEDICAL INTERNATIONAL, LTD. SX720448CZ 4129484

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown