BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE BASIC PACK

    MDR report key: 3024289 · Received March 27, 2013

    Report

    Report Number
    3005997949-2013-00004
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 26, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS, THEREFORE WE COULD NOT DETERMINE THE ROOT CAUSE FOR THE REPORTED EVENT.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. (B)(4): DEVICE NOT RETURNED TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "CUSTOMER NOTICED HOLE IN BACK TABLE COVER DURING PROCEDURE. BLOOD SEEPED THROUGH THE COVER ONTO THE TABLE AND CONTAMINATED IT." NO PATIENT INJURY. 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
    126395 STERILE BASIC PACK STERILE SURGICAL PACK KKX KIMBERLY-CLARK HEALTH CARE AC2350B

    Patients

    Seq Age Sex Outcome Treatment
    1