BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2890269 · Received December 29, 2012

    Report

    Report Number
    1416980-2012-08401
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE CUSTOMER IS NOT SURE ABOUT THE LOT NUMBER OF THE REPORTED PRODUCT AND HAS PROVIDED TWO DIFFERENCE LOT NUMBERS, 11J31V295 AND 11K01V564. A BATCH REVIEW WAS CONDUCTED ON BOTH OF THE REPORTED LOT NUMBERS AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PROCUREMENT MANAGER FROM A FACILITY REPORTED TO BAXTER (B)(6) THAT A MULTILAYER BAG SET HAD BAG BURST AT THE SEAM. THIS OCCURRED WHILE A TECHNICIAN WAS 'CRACKING IT'. THE BAG WAS FILLED WITH TOTAL PARENTERAL NUTRITION (TPN). 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 AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SET, I.V. FLUID TRANSFER KPE BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1