BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2851383 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06142
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    LHI
    PMA / PMN Number
    K973654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    BAXTER SALES REPRESENTATIVE REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A VIALMATE IN WHICH THE MEDICATION WAS LEAKING ONTO THE NURSES HANDS WHEN ATTEMPTING TO RECONSTITUTE. THE ALLEGED DEFECT OCCURRED WHEN THE NURSE ATTEMPTED TO RECONSTITUTE VANCOMYCIN. THEREFORE, THERE WERE NO REPORTS OF PATIENT INVOLVEMENT, PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1