BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW

    MDR report key: 484034 · Received September 11, 2003

    Report

    Report Number
    1450392-2003-00002
    Event Type
    Malfunction
    Date Received
    September 11, 2003
    Date of Event
    August 8, 2003
    Report Date
    August 11, 2003
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THE CLEAR VIEW SUBCUTANCOUS INFUSION NEEDLE SET LEAKED AT LUER/TUBING CONNECTIOIN DURING DESFERAL INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARVIEW SUBCUTANEOUS INFUSION NEEDLE SET LJT NORFOLK MEDICAL PRODUCTS, INC. * 3073

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR