BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORMAL SALINE PREFILLED FLUSH

    MDR report key: 324398 · Received March 29, 2001

    Report

    Report Number
    6000001-2001-00135
    Event Type
    Injury
    Date Received
    March 29, 2001
    Date of Event
    October 23, 2000
    Report Date
    March 1, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT FROM VOLUNTARY MEDWATCH INDICATES PT. C/O OF FEVER AND CHILLS AFTER FLUSHING THEIR CATHETER. PT SKIPPED ONE OF THE FLUSHINGS AND HAD NO FEVER OR CHILLS BUT THE NEXT DAY WHEN PT FLUSHED IT PT EXPERIENCED THE FEVER AND CHILLS AGAIN. ADD'L INFO REVEALS PT TRAVELED TO LOS ANGELES AND ON THEIR RETURN WAS ADMITTED TO THE HOSPITAL AND PSEUDOMONAS FLUOROSCENS WAS ISOLATED FROM BLOOD CULTURE. PT WAS HOSPITALIZED FOR 7 DAYS FOR IV ANTIBIOTICS AND RECOVERED. THE REPORT IDENTIFIED 2 DIFFERENT PRODUCTS THE PT WAS USING PRIOR TO THIS INFECTION: PRODUCT CODE: 2K0905; LOT # KH00207 & KH00221 (PREFILLED SALINE SYRINGES) 2K6049; LOT # B00079 & B03421B (NOT AN IDENTIFIED BAXTER LOT NUMBER) ( PREFILLED HEPARIN SYRINGES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13873 NORMAL SALINE PREFILLED FLUSH COMPASS PREFILLED SYRINGE FOZ BAXTER HEALTHCARE CORP. NA KH00207

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization