BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2830095 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04934
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 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). 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: FOUR UNUSED SAMPLES WERE AVAILABLE FOR EVALUATION. A VISUAL INSPECTION REVEALED PARTICULATE MATTER INSIDE THE FLUID PATH OF ALL OF THE RECEIVED SAMPLES. 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: THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PHARMACIST OF THE FACILITY REPORTED TO BAXTER (B)(4) OF AN ALL IN ONE EMPTY CONTAINER WITH CONNECTOR IN WHICH THE PHARMACIST OBSERVED AN UNKNOWN PARTICLE INSIDE THE SOLUTION BAG. THE REPORTED CONDITION OCCURRED BEFORE PATIENT USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR11E02085

    Patients

    Seq Age Sex Outcome Treatment
    1