BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLINK NEEDLE FREE SYSTEM

    MDR report key: 10567 · Received December 20, 1993

    Report

    Report Number
    MW1000144
    Event Type
    Injury
    Date Received
    December 20, 1993
    Date of Event
    November 17, 1993
    Report Date
    December 8, 1993
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IS A 3-YR-OLD S/P LIVER TRANSPLANT PT RECEIVING TPN VIA HICKMAN CATHETER WHICH HAS BEEN IN PLACE FOR LESS THAN 1 YR. PT BEGAN USING INTERLINE BRAND SEPING CANNULAS IN 7/93. SINCE THAT TIME, SHE HAS HAD 3 EPISODES OF CONFIRMED SEPSIS/BACTEREMIA. ON 11/17, SHE WAS ADMITTED WITH YEAST SEPSIS (HER 3RD SEPTIC ADMISSION) AND REQUIRED ICU ADMISSION FOR STABILIZATION.SHE HAD HER CATHETER REPLACED AND WILL NOW RECEIVE TPN AND AMPHOTERICIN. (SEE PREVIOUS REPORT, FILE NO 1113309 REGARDING PRODUCT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK NEEDLE FREE SYSTEM SEPING CANNULAS, INTERLINK CAPS FOZ BAXTER HEALTHCARE CORP. MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 3 * Hospitalization| L| R AVI TUBING P PUMPS.| SOLOPAK PREFILLED SYRINGES, AVI TUBING P PUMPS.