BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2233710 · Received September 2, 2011

    Report

    Report Number
    6000001-2011-22567
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN USED SAMPLE ENCLOSED IN A PLASTIC BAG WAS RECEIVED AT THE PLANT FOR EVALUATION. THE UNIT WAS VISUALLY INSPECTED AND THE TUBE WAS CUT, HENCE THE DEFECT REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THIS CONDITION IS UNKNOWN. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. 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) TO MANAGE THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A VENTED PACLITAXEL SET THAT WAS LEAKING. THE SOURCE OF THE LEAK WAS IN A NUMBER OF AREAS RUNNING DOWN THE LINE. A PATIENT WAS INVOLVED BUT NO INJURY WAS INCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS

    Patients

    Seq Age Sex Outcome Treatment
    1