BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3200750 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16980
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    LHI
    PMA / PMN Number
    K973654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VIAL-MATE RECONSTITUTION DEVICE HAD LEAKED. THE LEAK WAS FROM BETWEEN THE BAG AND THE ADAPTER. THE LEAK WAS NOTICED AFTER SPIKING THE BAG IN THE MEDICAL SURGERY DEPARTMENT. THE CUSTOMER STATED THAT THE LEAK OCCURS WHEN THE FLUID IS SENT INTO THE VIAL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297762 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - CLEVELAND GR13B04011

    Patients

    Seq Age Sex Outcome Treatment
    1