BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2760946 · Received September 26, 2012

    Report

    Report Number
    1416980-2012-00778
    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). DEVICE EVALUATION: 68 UNUSED SAMPLES WERE AVAILABLE FOR EVALUATION. A VISUAL INSPECTION REVEALED PARTICULATE MATTER INSIDE THE FLUID PATH OF THE BAG IN 13 OUT OF 68 RECEIVED BAGS. THE REPORTED CONDITION WAS CONFIRMED FOR THIS SAMPLE. NO OTHER TESTS WERE PERFORMED. THE ASSIGNABLE ROOT CAUSE FOR THE REPORTED CONDITION IS UNKNOWN. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (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 TAIWAN 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, IV KPE BAXTER HEALTHCARE - AIBONITO UR12D18141

    Patients

    Seq Age Sex Outcome Treatment
    1