BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3252963 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-20072
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: TWO (2) USED UNITS WERE RECEIVED FOR EVALUATION. THE BAGS CONTAINED WHITE LIQUID. VISUAL INSPECTION WAS PERFORMED AND DURING THE INITIAL VISUAL INSPECTION THE PARTICULATE MATTER (PM) WAS NOT OBSERVED, SINCE THE BAGS CONTAINED WHITE LIQUID. THE PM WAS OBSERVED AFTER THE LIQUID WAS FILTERED. NO OTHER TESTS WERE PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS DUE TO THE MATERIAL SUPPLIED TO MANUFACTURING FACILITY. THE ISSUE IS BEING FURTHER INVESTIGATED AT THE SUPPLIER?S FACILITY. A BATCH REVIEW WAS PERFORMED, AND NO DEVIATIONS WERE FOUND DURING THE MANUFACTURING OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SECOND RETURNED SAMPLE IS ADDRESSED IN A SEPARATE REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4) THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED INSIDE AN INTRAVIA 150 ML CONTAINER CONTAINING DEFEROXAMINE. THIS ISSUE WAS DISCOVERED BEFORE USE, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352257 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR13D15112

    Patients

    Seq Age Sex Outcome Treatment
    1