BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2152085 · Received July 7, 2011

    Report

    Report Number
    6000001-2011-10648
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE USED IN THIS SITUATION IS 510(K) EXEMPT - (B)(4); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A VENTED SPIKE ADAPTER THAT BROKE. ACCORDING TO THE REPORT, WHEN THE ADAPTER WAS REMOVED FROM AN IUIG BOTTLE, THE ADAPTER WAS IN TWO PIECES. THE USER WAS ABLE TO RECTIFY THE SITUATION BY REMOVING THE SPIKE PART THAT REMAINED IN THE BOTTLE AND USING A NEW VENTED SPIKE ADAPTER. THE CONDITION OCCURRED PRIOR TO PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE R10L07165

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IUIG BOTTLE