BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACACIA TUBING BX01

    MDR report key: 198866 · Received November 20, 1998

    Report

    Report Number
    MW1015041
    Event Type
    Malfunction
    Date Received
    November 20, 1998
    Report Date
    November 20, 1998
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTAL END BECOMES INOPERABLE AFTER A HOLE FORMS. FLUID SHOOTS FROM THE HOLE AND CAUSES EMPLOYEES TO CHANGE TUBING AND DEVICE WHICH FLUID IS BEING TRANSFERRED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACACIA TUBING BX01 PHARM-ASSIST DISPENSING PUMP TUBING SET LHI EXCELSIOR MEDICAL CORP. BX01 SINGLE LEAD 180819

    Patients

    Seq Age Sex Outcome Treatment
    1 *