BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY INTRAVIA CONTAINER (1000ML) GAMMA STERILIZED

    MDR report key: 1891179 · Received November 4, 2010

    Report

    Report Number
    6000001-2010-04718
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS AVAILABLE BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL USED SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THERE WAS NO PARTICULATE MATTER OBSERVED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA NC-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER OF A FILAMENT, WHICH APPEARS TO BE A FLOATING THREAD-LIKE PIECE OF PLASTIC IN THE 1000ML INTRAVIA EMPTY CONTAINER. THERE IS ONLY THE ONE FLOATER. THE PRODUCT WAS ALREADY FILLED AND HAS SOME COMBINATION OF SODIUM CHLORIDE, CALCIUM GLUCONATE, SODIUM ACETATE, OR POTASSIUM CHLORIDE. THE FILAMENT CANNOT BE SEEN UNTIL THE BAG IS BEING FILLED. THE CUSTOMER PERSONALLY CHECKS EACH BAG BEFORE THEY ARE FILLED AND IS NEVER ABLE TO SEE ANY PARTICULATES BEFORE USE. AN UNKNOWN FILTER NEEDLE IS INJECTED INTO THE ADDITIVE PORT OF THE BAG, THEN A BBRAUN IN2000 STOPPER IS CONNECTED TO THE OTHER END OF THE FILTER NEEDLE. THIS SEQUENCE OF PRODUCTS IS USED SO THAT THE BAG IS ONLY PUNCTURED ONCE BY THE FILTER NEEDLE, AND THEN THE FILTER IS ACCESSED NUMEROUS TIMES. THE BBRAUN STOPPER IS USED ON THE END OF THE FILTER NEEDLE AS A PORT SAVER. THERE WAS NO PATIENT INVOLVEMENT AS THE CONDITION IS OBSERVED DURING FILLING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPTY INTRAVIA CONTAINER (1000ML) GAMMA STERILIZED CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR10H02155

    Patients

    Seq Age Sex Outcome Treatment
    1