BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2162697 · Received July 14, 2011

    Report

    Report Number
    6000001-2011-11962
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED DUE TO CHEMOTHERAPY CONTAMINATION. SINCE THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES 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 2-LEAD SOLUTION ADMINISTRATION SET IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, THE SET WAS LEAKING BY THE OUTLET CONNECTOR. THE SET WAS FILLED WITH CYTOSTATICA AND WAS DISCARDED IMMEDIATELY BY THE CUSTOMER. THE CONDITION OCCURRED DURING FULLING AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10J05V067M

    Patients

    Seq Age Sex Outcome Treatment
    1