BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 DROP ADMINISTRATION SET WITH INTEGRATED CLAVE DRIP

    MDR report key: 1920890 · Received December 8, 2010

    Report

    Report Number
    MW5018522
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ICU MEDICAL INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING PREMETREXED/CARBOPLATIN CHEMOTHERAPY TREATMENT. AT THE END OF THE TREATMENT A LONG THIN FILAMENT DESCRIBED AS HAIR LIKE BY THE NURSE WAS NOTICED IN THE SAFETY TUBING DRIP CHAMBER. THE NURSE CALLED THE PHARMACY AND HER NURSE MANAGER. ALL TUBING WITH THE SAME LOT NUMBER WERE COLLECTED AND THE COMPANY NOTIFIED. THE COMPANY REP FELT THAT THIS WOULD HAVE OCCURRED DURING MANUFACTURING AND IT IS THEREFORE STERILE. THE NAME OF THE TUBING: 30" APPX. 3.2ML. 20 DROP ADMINISTRATION SET W/INTEGRATED CLAVE DRIP CHAMBER, SPIROS, HANGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20 DROP ADMINISTRATION SET WITH INTEGRATED CLAVE DRIP IV TUBING FPA ICU MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR