BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2073517 · Received April 20, 2011

    Report

    Report Number
    2073517
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 5, 2011
    Manufacturer
    HOSPIRA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    DEXTROSE 5% WITH 20 MEQ (MILLIEQUIVALENT) POTASSIUM CHLORIDE (KCL) ORDERED TO BE STARTED ON PATIENT. WHEN BAG OVERWRAP WAS REMOVED, THE IV BAG AREA TO BE SPIKED WAS MISSING THE REMOVABLE STOPPER AND SEEMED "MAL-FORMED." IT APPEARED ALMOST MELTED. THE BAG WAS NOT USED ON THE PATIENT, WAS REPLACED AND THERE WAS NO PATIENT HARM. THE REMAINING LOT WAS INSPECTED AND APPEARED TO NOT BE AFFECTED/ISOLATED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * IV BAG KPE HOSPIRA * 84-530-FW

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR NO OTHER THERAPIES