BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEST TUBE PLACEMENT CUSTOM KIT

    MDR report key: 6584055 · Received May 23, 2017

    Report

    Report Number
    6584055
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Date of Event
    May 17, 2017
    Report Date
    May 17, 2017
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOM TRAYS FROM AMERICAN CONTRACT SYSTEMS (VARIOUS TYPES) PREVIOUSLY HAD LIDOCAINE PACKAGED INSIDE THE TRAY. HOWEVER, THE MANUFACTURER NOW ADDS THE LIDOCAINE ON THE OUTSIDE. CONCERN THAT THE LIDOCAINE MIGHT BE SEPARATED FROM THE TRAY YET IT IS STILL LISTED AS CONTENTS AND THE USER MAY NOT BE AWARE WITH THE MAIN PACKAGING INTACT. ALSO MAY BE AN UNSAFE WAY TO STORE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366123 CHEST TUBE PLACEMENT CUSTOM KIT CUSTOM PROCEDURE SUPPLY KIT LRO AMERICAN CONTRACT SYSTEMS 893171

    Patients

    Seq Age Sex Outcome Treatment
    1