BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLSA DE EVA 3000ML

    MDR report key: 1912007 · Received December 1, 2010

    Report

    Report Number
    6000001-2010-05355
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    September 27, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    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. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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) A 3000ML EVA BAG IN WHICH THE MAIN SEAL WAS LEAKING. THE CONDITION WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOLSA DE EVA 3000ML CONTAINER, I.V. KPE BAXTER HEALTHCARE - SAO PAULO PE27P2

    Patients

    Seq Age Sex Outcome Treatment
    1