BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL DECANTER FOR ASEPTIC TRANSFER OF FLUIDS FROM SMALL VIALS

    MDR report key: 4209969 · Received October 22, 2014

    Report

    Report Number
    1037885-2014-00001
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Product Code
    KPE
    PMA / PMN Number
    K852893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL REMAINING INVENTORY OF THE USED LOT IN QUESTION HAS BEEN PLACED IN AMD'S QUARANTINE AREA TO BE 100% INSPECTED BY AMD'S QUALITY DEPARTMENT.

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: THE TWO PIECES OF THE VIAL DECANTER SEPARATED WHEN THEY TRIED TO USE IT. OPENED SECOND DEVICE - SAME ISSUE - SAME LOT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? TO DECANT MEDICATIONS FROM A VIAL PRIOR TO AN OPERATING ROOM PROCEDURE. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672374 VIAL DECANTER FOR ASEPTIC TRANSFER OF FLUIDS FROM SMALL VIALS CONTAINER, I.V. KPE ADVANCE MEDICAL DESIGNS, INC. 10-106 40134C4020

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIOR TO SURGICAL PROCEDURE