BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1243114 · Received November 21, 2008

    Report

    Report Number
    1423500-2008-00924
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 13, 2008
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER PRODUCT SURVEILLANCE STATING THAT A TRANSFER SET HAD FALLEN OFF A CATHETER ON A HOME PT. THE TRANSFER SET HAD BEEN IN PLACE FOR ABOUT TWO WEEKS. THE ADAPTOR WAS PLASTIC AND THE INITIAL CONNECTION WAS MADE BY HAND. THE REPORTED SEPARATION TOOK PLACE AT THE TRANSFER SET ADAPTOR/CATHETER INTERFACE. THE HOME PATIENT WAS GIVEN 1 GRAM OF VANCOMYCIN FOR ONE DAY PROPHYLACTICALLY. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1