BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE WATER FOR IRRIGATION

    MDR report key: 2240683 · Received August 26, 2011

    Report

    Report Number
    2240683
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 26, 2011
    Manufacturer
    HOSPIRA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF OPENED A LITER BOTTLE OF STERILE WATER AND NOTED THAT THERE APPEARED TO BE A SMALL AMOUNT OF AN UNKNOWN SUBSTANCE ON THE TOP OF THE BOTTLE OPENING. THE SUBSTANCE IS BLACK IN COLOR AND RESEMBLES MOLD. NO PATIENT WAS INVOLVED IN THIS EVENT. STAFF WERE PREPARING THE ENDOSCOPY ROOM FOR USE THAT MORNING. STAFF HAVE NOT SEEN THIS BEFORE. THE BOTTLE HAD BEEN STORED IN A SECURE CABINET DEVOID OF LIGHT AND AT ROOM TEMPERATURE. ALL OTHER BOTTLES IN THE CABINET WERE INSPECTED AND NO OTHER HAD SUCH A SUBSTANCE ON THEM. THERE WERE MULTIPLE LOTS STORED IN THIS AREA, INCLUDING OTHERS OF THE SAME LOT AS THIS ONE AFFECTED LITER OF STERILE WATER. THE MOLD-LIKE SUBSTANCE WAS DISCOVERED WHEN THE BOTTLE WAS OPENED. THE BOTTLE ITSELF WAS INTACT--NO CRACKS, LEAKS, OR OPENINGS. THE BOTTLE LID WAS SECURELY FASTENED AS EXPECTED. THE BOTTLE WAS FULL WHEN THE SUBSTANCE WAS DISCOVERED. THERE WAS NO DISCOLORATION TO THE BOTTLE OR THE FLUID INSIDE IT. THERE WERE NO PARTICULATES OR FLOATERS IN THE STERILE WATER AND IT WAS ODORLESS. THE MANUFACTURER WAS NOTIFIED AND THE BOTTLE WAS SENT TO THEM FOR INSPECTION/ANALYSIS.======================MANUFACTURER RESPONSE FOR 1 LITER POUR BOTTLE OF STERILE WATER, STERILE WATER FOR IRRIGATION (PER SITE REPORTER)======================HOSPIRA WAS NOTIFIED OF THE EVENT. THE BOTTLE AND ITS CAP WERE RETURNED TO THE MANUFACTURER FOR INSPECTION AND ANALYSIS. WE ARE WAITING TO HEAR BACK FROM THEM REGARDING THEIR FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE WATER FOR IRRIGATION STERILE WATER KPE HOSPIRA * 037454B

    Patients

    Seq Age Sex Outcome Treatment
    1 *