BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2761229 · Received September 26, 2012

    Report

    Report Number
    1416980-2012-00818
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K090096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AN UNUSED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE OBSERVED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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.

    Description of Event or Problem · 1

    THE FACILITY'S COMPOUNDING PHARMACIST REPORTED TO BAXTER (B)(4) THAT AN ALL-IN-ONE EMPTY CONTAINER HAD FOREIGN MATTER INSIDE THE BAG. THIS CONDITION WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR08L10171

    Patients

    Seq Age Sex Outcome Treatment
    1