BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLSA VACIA 3L EVA TRES VIAS DE TRANSFERENCIA CON DESCONEXIO

    MDR report key: 1850503 · Received October 1, 2010

    Report

    Report Number
    6000001-2010-03676
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    BTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS EVALUATED WITH VISUAL INSPECTION AND LEAK TEST. THE BAG LEAK WAS DETERMINED TO BE AT THE SEAL OF THE PORT AND BAG. THE LEAK WAS CAUSED BY THE WEARING OUT OF THE SEALING APPARATUS ON THE BAG ASSEMBLY EQUIPMENT. AS CORRECTIVE ACTIONS, THE SEALING APPARATUS WAS REPLACED ON THE MACHINE AND A SUCCESSFUL LEAK TEST WAS PERFORMED ON THE PRODUCT. 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) OF ONE EVA 3L EMPTY BAG IN WHICH ONE OF THE TUBES FELT OFF DURING THE USE. THE SAMPLE IS AVAILABLE. PATIENT INJURY AND MEDICAL INTERVENTION WERE NOT REPORTED FOR THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOLSA VACIA 3L EVA TRES VIAS DE TRANSFERENCIA CON DESCONEXIO BAG, RESERVOIR BTC BAXTER HEALTHCARE - CALI SX10EF6

    Patients

    Seq Age Sex Outcome Treatment
    1