BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA EMPTY CONTAINER (250ML) GAMMA STERILIZED

    MDR report key: 1900703 · Received November 16, 2010

    Report

    Report Number
    6000001-2010-04921
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL UNIT FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER THAT SOMETHING RESEMBLING PLASTIC OR CORING WAS FOUND IN THE (B)(4) SET WHICH WAS CONNECTED TO A 250ML INTRAVIA CONTAINER FILLED WITH FLUOROURACIL AND NORMAL SALINE. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAVIA EMPTY CONTAINER (250ML) GAMMA STERILIZED CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR10F01136

    Patients

    Seq Age Sex Outcome Treatment
    1