BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN US CORPORATION

    MDR report key: 313044 · Received January 18, 2001

    Report

    Report Number
    MW1020844
    Event Type
    Malfunction
    Date Received
    January 18, 2001
    Date of Event
    January 14, 2001
    Report Date
    January 18, 2001
    Manufacturer
    CODAN U.S. CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT EPIDURAL CATHETER "SEPARATED" AT SITE OF CONNECTION TO FILTER. ON INSPECTION IT WAS NOTED THAT 60" EXTENSION TUBING (BC 566 LUER-LOCK-EXTENSION SET) HAD INFACT SEPARATED AT SITE OF "MALE" LUER-CONNECTOR. NO SIGNS OF STRESS TO TUBING. NEW TUBING WAS ASSEMBLED, PRIMED AND CONNECTED TO INFUSION PUMP AND INFUSION RESTARTED. PT REMAINED COMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2455 CODAN US CORPORATION BC 566 LUER-LOCK-EXTENSION SET FPA CODAN U.S. CORP. * 72011

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR