BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3110276 · Received May 13, 2013

    Report

    Report Number
    1416980-2013-12223
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION DID NOT IDENTIFY PARTICULATE MATTER. THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: IN ADDITION TO THE PREVIOUSLY REPORTED EVALUATION OF THE RETURNED SAMPLE, PHOTOGRAPHS HAVE BEEN PROVIDED OF THE ACTUAL DEVICE. DURING PHOTOGRAPHIC INSPECTION A BROWN SPOT WAS OBSERVED ON OR WITHIN THE DEVICE; HOWEVER, THIS WAS NOT OBSERVED WITH THE RETURNED DEVICE. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION ACCORDING TO THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE "BLACK MARKS ON THE OUTSIDE AND INSIDE OF THE TUBING LINE" OF AN AUTOMIX COMPOUNDER TRANSFER SET. ACCORDING TO THE CUSTOMER, THIS WAS SEEN ALL THE WAY FROM THE "WHITE PORT LEADING TO THE ORANGE PORT, AND THE BLACK ON THE OUTSIDE CAN BE WIPED OFF VERY EASILY." THE EVENT OCCURRED BEFORE USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211298 IVT DISPOSABLE SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1