BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2103070 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06505
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    PLASTI ESTERIL, S.A. DE C.V.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE WERE RECEIVED BY THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION CONFIRMED A SMALL CUT ON THE PRIMARY PACKAGING OF THE TRANSVERSAL SEAL. THE MANUFACTURING FACILITY HAS INDICATED THIS WAS CAUSED BY A FAILURE OF THE PACKAGING MACHINE DURING MANUFACTURING. AN INVESTIGATION WAS CONDUCTED BY THE MANUFACTURING FACILITY AND CORRECTIVE ACTIONS WERE IMPLEMENTED. SIMILAR REPORTS HAVE BEEN RECEIVED; BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS AVAILABLE FOR EVALUATION.A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THIS IS AN INTERNATIONAL REPORT WHERE A PATIENT IDENTIFIED 1 CASSETTE IN WHICH THE OVERPOUCH BROKEN. THERE WAS NO PATIENT INVOLVEMENT, THE PRODUCT WAS NOT USED. THIS IS REPORT 3 OF 3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX PLASTI ESTERIL, S.A. DE C.V. 14SAHC

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE