BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP

    MDR report key: 493390 · Received October 29, 2003

    Report

    Report Number
    1423500-2003-01108
    Event Type
    Other
    Date Received
    October 29, 2003
    Date of Event
    September 29, 2003
    Report Date
    September 29, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN REPORTED A HOME PATIENT EXPERIENCED A LEAK IN THE TWIST CLAMP AREA OF THE TRANSFER SET AFTER SHOWERING. THE HOME PATIENT WAS SEEN IN THE CLINIC FOR A CATHETER IRRIGATION AND EXPERIENCED CLOUDY EFFLUENT, ABDOMINAL PAIN AND FEVER. THE PATIENT RECEIVED A TRANSFER SET CHANGE AND WAS TREATED WITH IP VANCOMYCIN 1GM. PROPHYLACTICALLY. NO PATIENT SEQUELAE RESULTED PER RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP TRANSFER SET KDJ BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention