BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3080286 · Received April 26, 2013

    Report

    Report Number
    1416980-2013-10483
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED, THEREFORE NO EVALUATION COULD BE PERFORMED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE ELEVEN MINICAPS WHICH WERE OBSERVED TO HAVE "NO IODINE". THE EVENT OCCURRED PRIOR TO PATIENT USE, FOR PERITONEAL DIALYSIS THERAPY. THE MINICAP HAD NOT BEEN USED. THIS IS REPORT 1 OF 11 ASSOCIATED IN THIS EVENT, WITH THIS LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181011 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893883

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR