BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT CLOSED SUCTION SYSTEM

    MDR report key: 2100897 · Received May 24, 2011

    Report

    Report Number
    8030647-2011-00030
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    March 31, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWS THE PRODUCT MET ALL SPECIFICATIONS. THE SAMPLE ANALYSIS SHOWED A NON UNIFORM EDGE ON THE TIP OF THE 'Y' ADAPTER. THE ROOT CAUSE FOR DAMAGE TO THIS POLYMER MOLDED COMPONENT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM THE (B)(6), STATING, "IRREGULARITIES AND ABRASIONS ON 'Y' ADAPTER." PHOTOS SHOW AN AREA OF IRREGULARITY ON THE TIP INDICATING A POSSIBLE CHIP IN THE CONNECTOR. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMVENT CLOSED SUCTION SYSTEM CLOSED SUCTION BSY KIMBERLY-CLARK HEALTH CARE M8345T704

    Patients

    Seq Age Sex Outcome Treatment
    1