BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER SUCT 8FR W/CONTROL COILED

    MDR report key: 2424109 · Received January 20, 2012

    Report

    Report Number
    8030673-2012-00090
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    February 3, 2010
    Report Date
    February 3, 2010
    Manufacturer
    CAREFUSION
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS EVALUATED FOR ANY ISSUES RELATED WITH THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH INTERNAL PROCEDURES AND NO ISSUES WERE NOTED. THE ROOT CAUSE IS BELIEVED TO BE A FAILURE IN THE ASSEMBLY AREA. ASSEMBLY PERSONNEL FAILED TO FOLLOW THE MANUFACTURING PROCEDURE WHICH INDICATES WHERE TO ASSEMBLE THE CONNECTOR. TO CORRECT THIS ISSUE, VISUAL AIDS WILL BE PLACED FRONT OF THE OPERATOR AND WORKSTATION. CONTAINERS WILL BE PLACED IN THE WORK STATION TO DIFFERENTIATE MATERIAL IN PROCESS. CAREFUSION 2200 INC. POST-MARKET SURVEILLANCE WAS HISTORICALLY MANAGED BY CARDINAL HEALTH VIA A TRANSITIONAL SERVICE AGREEMENT FROM SEPTEMBER 1, 2009, THROUGH JULY 1, 2011, SINCE CAREFUSION OFFICIALLY SPUN OFF FROM CARDINAL HEALTH AS OF SEPTEMBER 1, 2009. A RETROSPECTIVE REVIEW OF ALL COMPLAINTS DURING THIS TIMEFRAME WAS CONDUCTED BY THE NEW CAREFUSION CUSTOMER ADVOCACY CLINICAL TEAM IN ACCORDANCE WITH INTERNAL STANDARD OPERATING PROCEDURES AND IT WAS DETERMINED THAT THIS EVENT NECESSITATES SUBMISSION AS A MEDICAL DEVICE REPORTABLE (MDR) IN ACCORDANCE WITH 21 CODE OF FEDERAL REGULATION (CFR) PART 803.

    Description of Event or Problem · 1

    CAREFUSION RECEIVED A REPORT INDICATING A SUCTION CATHETER, PART T64C, THAT WAS ATTACHED TO THE CONTROL ADAPTER BACKWARDS.  THE TIP OF THE CATHETER WAS INCORRECTLY GLUED TO THE ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER SUCT 8FR W/CONTROL COILED CATHETERS, SUCTION, TRACHEOBRONCHIAL BSY CAREFUSION T64C

    Patients

    Seq Age Sex Outcome Treatment
    1