BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC LAPAROTOMY DRAPE II WITH ARMBOARD COVERS

    MDR report key: 2912146 · Received January 11, 2013

    Report

    Report Number
    1033422-2013-00002
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 13, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 RETURNED DEVICE WAS EVALUATED AND DETERMINED THAT THE LOCATION OF THE SEAL THAT FAILED WAS TOO CLOSE TO THE EDGE OF THE PACKAGE ALLOWING THE PACKAGE TO OPEN PRIOR TO RECEIPT BY THE CUSTOMER. THE SEAL FAILURE WAS IDENTIFIED PRIOR TO USE. CHANGES TO THE MANUFACTURING PROCESS HAVE BEEN IMPLEMENTED TO PREVENT RECURRENCE AND ARE BEING VERIFIED. NO ADDITIONAL UNITS FROM EFFECTED LOT HAVE BEEN IDENTIFIED, AND EVALUATION OF UNITS IN INVENTORY IS ONGOING. 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 (B)(6), STATING, "THE WIDTH OF SIDE SEALING IS TOO THIN AND OPENED WHEN USER RECEIVED IT." 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18937 PEDIATRIC LAPAROTOMY DRAPE II WITH ARMBOARD COVERS STERILE SURGICAL DRAPE KKX KIMBERLY-CLARK HEALTH CARE GL2062FAA

    Patients

    Seq Age Sex Outcome Treatment
    1