BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER ACCESS PORT KIT

    MDR report key: 3040078 · Received April 1, 2013

    Report

    Report Number
    MW5029622
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SIDE PORT ASPIRATION OF ITB PUMP WAS IN THE PROCESS OF BEING PERFORMED. A CATHETER ACCESS PORT KIT FROM MEDTRONIC 8540 WAS TO BE USED. WHEN THE DRAPE WAS REMOVED FROM THE STERILE TRAY, A VERY LONG BLACK HAIR WAS NOTED TO BE INTERTWINED INSIDE THE FOLDS OF THE DRAPE. ON (B)(6) 2013 BACLOFEN PUMP REFILL WAS IN THE PROCESS OF BEING PERFORMED. WHEN THE STERILE KIT WAS OPENED THERE WAS A LONG BLACK HAIR NOTED STICKING OUT OF THE STERILE DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132411 CATHETER ACCESS PORT KIT REFILL KIT LKK MEDTRONIC C50082
    132412 CATHETER ACCESS PORT KIT REFILL KIT LKK MEDTRONIC 2012092490

    Patients

    Seq Age Sex Outcome Treatment
    1