BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1243078 · Received November 20, 2008

    Report

    Report Number
    1423500-2008-00920
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 13, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER PRODUCT SURVEILLANCE STATING THAT A TRANSFER SET HAD FALLEN OFF THE CATHETER OF A HOME PATIENT. THE TRANSFER SET HAD BEEN IN PLACE FOR ABOUT TWO WEEKS. THIS WAS A PLASTIC ADAPTOR AND THE INITIAL CONNECTION WAS MADE BY HAND. THE SEPARATION OCCURRED AT THE TRANSFER SET ADAPTOR / CATHETER INTERFACE. THE NURSE DID NOT KNOW WHAT MIGHT HAVE CAUSED THE TRANSFER SET TO HAVE FALLEN OFF. THIS PATIENT DEVELOPED PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP 78KDJ KDJ BAXTER HEALTHCARE H07J26024

    Patients

    Seq Age Sex Outcome Treatment
    1