BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP WITH POVIDONE LODINE

    MDR report key: 1973218 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01239
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    November 5, 2010
    Report Date
    November 15, 2010
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE ACTUAL SAMPLE WAS RECEIVED AND VISUALLY INSPECTED. THE MINI-CAP WAS STILL HERMETICAL WHEN THE TRANSLUCENT FILM WAS SEPARATED COMPLETELY FROM ALUMINUM FOIL. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORTED CONDITION WAS DUE TO THE MANUFACTURING PROCESS OF THE ALUMINUM FOIL SUPPLIER. RENAL QUALITY ENGINEERING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES PRODUCT SAMPLE QUANTITY 17 OF 43. A CUSTOMER REPORTED TO BAXTER (B)(4) THAT THE FOIL OF THE PACKAGE WAS SEPARATED COMPLETELY BEFORE TEARING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP WITH POVIDONE LODINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GM1003009

    Patients

    Seq Age Sex Outcome Treatment
    1