BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUIBAND EXCEED

    MDR report key: 8864736 · Received August 6, 2019

    Report

    Report Number
    3009549229-2019-00001
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    June 5, 2019
    Report Date
    August 5, 2019
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
    Product Code
    MPN
    PMA / PMN Number
    K162322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT AFTER INITIAL PLACEMENT OF THE CATHETER INTO THE PATIENT'S ARM, BLOOD APPEARED TO BE LEAKING FROM THE CATHETER HUB (A SKIN SURFACE COMPONENT OF THE DEVICE). THE NURSE PROCEEDED IN CLEANING THE AREA OF BLOOD AND FLUSHING THE CATHETER WAS SALINE FLUID. SUBSEQUENTLY AFTER THE FLUSH, THE SALINE FLUID APPEARED TO BE LEAKING FROM THE CATHETER HUB. THE CATHETER WAS REMOVED AND REPLACED FOR A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658921 LIQUIBAND EXCEED TOPICAL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD

    Patients

    Seq Age Sex Outcome Treatment
    1