BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA BAG-500ML

    MDR report key: 1860561 · Received October 7, 2010

    Report

    Report Number
    6000001-2010-03846
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    BTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. THE BATCH REVIEW WAS COMPLETED FOR THE REPORTED LOT AND NO DEVIATIONS WERE FOUND. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN EVA BAG THAT PRESENTED A LEAK. THE CONDITION OCCURRED DURING FILLING. 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 EVA BAG-500ML BAG, RESERVOIR BTC BAXTER HEALTHCARE - SAO PAULO PE28N1

    Patients

    Seq Age Sex Outcome Treatment
    1