BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR LIFE PRE-FILL

    MDR report key: 2176908 · Received July 14, 2011

    Report

    Report Number
    2176908
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 5, 2011
    Report Date
    July 11, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPLACEMENT BOTTLE FOR AIRLIFE PRE-FILL NEBULIZER KIT (B)(4) WAS LABELED AS BEING OPENED (B)(6) 2011 AT 0200. WITHIN 24 HOURS OF BOTTLE BEING OPENED, WHEN STAFF POURED STERILE WATER FROM THE BOTTLE TO FILL HI-FLOW CANNULA NEBULIZER CONTAINER, THE STERILE WATER BEGAN FOAMING AND SMELLED STRONGLY OF SULFUR. THE SOLUTION WAS SLIGHTLY DISCOLORED. LOT # ZI-0211001 2013-02. A SECOND BOTTLE OF THE SAME LOT NUMBER WAS OPENED AND HAD NO ODOR. A THIRD BOTTLE, LOT # LP 0810006 2012-08 WAS OPENED ON (B)(6) 2011 AND HAD A STRONGER ODOR THAN SECOND BOTTLE, BUT NOT AS STRONG AS INITIAL BOTTLE. THERE WAS NO DISCOLORATION OF THE SOLUTION. ALL BOTTLES WERE CLEARLY LABELLED WITH FINDINGS AND RETURNED TO COMPANY. THE COMPANY WAS CALLED AND NOTIFIED OF THE FINDINGS. ALL PRODUCTS (B)(4) LOT # ZI-0211001 2013-02 WERE RETURNED TO COMPANY AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR LIFE PRE-FILL NEBULIZER KIT CAF CAREFUSION ZI-0211001
    2 AIR LIFE PRE-FILL NEBULIZER KIT CAF CAREFUSION LP 0810006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other