BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT READY CARE ORAL CARE SUCTION PROBE

    MDR report key: 1831569 · Received September 10, 2010

    Report

    Report Number
    8030647-2010-00009
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Report Date
    August 12, 2010
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO SEARCH THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED. NO SAMPLE WAS RETURNED FOR EVALUATION. LABELING INDICATES THIS PRODUCT IS SINGLE USE ONLY. 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. DEVICE NOT RETURNED BY CUSTOMER TO KIMBERLY-CLARK.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "TIP OF CATHETER COMES APART. THEY USE IT UNTIL IT IS DIRTY." 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 READY CARE ORAL CARE SUCTION PROBE ORAL CARE KXF NONE PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1