BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1251702 · Received December 2, 2008

    Report

    Report Number
    1423500-2008-00960
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    April 1, 2008
    Report Date
    November 12, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK AND THE SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THIS IS A CASE REPORTED FROM ANOTHER COUNTRY'S CO; THE COMPETENT AUTHORITY. THE DIALYSIS CENTRE PHYSICIAN REPORTED TO BAXTER THAT IN 2008, THE PT USED THE MINICAP TRANSFER SET WHICH DID NOT CLOSE PROPERLY RESULTING IN PERITONITIS. THE PT RECEIVED TWO WEEKS OF ANTIBIOTIC THERAPY OF TARGOSID (TEICOPLANIN) AND NEBICINA (TOBRAMYCIN). THE PT OUTCOME IS UNK. THE SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP 78KDJ KDJ BAXTER HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention