BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVACUATED GLASS CONTAINER

    MDR report key: 3161414 · Received May 30, 2013

    Report

    Report Number
    3161414
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GLASS BOTTLE WAS DROPPED IN APPROPRIATE DISPOSAL CONTAINER AND SHATTERED RESULTING IN PLEURAL FLUID SPLASHING IN TECHNICIAN'S FACE. STAFF HAVE IMPLEMENTED PROCESS OF USING ADDITIONAL PPE (PERSONAL PROTECTIVE EQUIPMENT) WITH FACE PROTECTION FROM SPLASHING. STAFF ARE LOOKING FOR ALTERNATIVE BOTTLES, BUT STATED THERE IS NOT A PLASTIC ALTERNATIVE. WE STARTED USING THE GLASS BOTTLES AFTER STOPPING THE USE OF A DIFFERENT FLUID EVACUATION DEVICE. PATHOLOGY AND MICROBIOLOGY HAVE VOICED NO CONCERNS OR INCIDENTS OF BOTTLES BREAKING.TWO OTHER INSTANCES HAVE BEEN INVOLVED WITH THE GLASS BOTTLES SHATTERING AND THEN SPILLING CONTENTS, BUT ONE INCIDENT INVOLVED STAFF EXPOSURE. IN THAT CASE, THE STAFF MEMBER UNDERWENT EXPOSURE TESTING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DISPOSAL OF EVACUATED CONTAINER AFTER FLUID REMOVAL FROM PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238578 EVACUATED GLASS CONTAINER CONTAINER, I.V. KPE BAXTER HEALTHCARE CORPORATION 00085412046167 6107367
    238579 EVACUATED GLASS CONTAINER CONTAINER, I.V. KPE BAXTER HEALTHCARE CORPORATION 00085412046167 6107367
    238627 EVACUATED GLASS CONTAINER CONTAINER, I.V. KPE BAXTER HEALTHCARE CORPORATION 00085412046167 6107367

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO