BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 150036 · Received February 16, 1998

    Report

    Report Number
    1423500-1998-00095
    Event Type
    Malfunction
    Date Received
    February 16, 1998
    Date of Event
    January 24, 1998
    Report Date
    January 28, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN REPORTS A LEAK WITH A TRANSFER SET NOTED DURING USE. HOME PT PRESENTED TO UNIT WITH UNK GROWTH PERITONITIS. PT TREATED AS AN OUTPATIENT WITH IP ANTIBIOTICS AND HAS RECOVERED FULLY.

    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 H97D22232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other