BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETE

    MDR report key: 2221601 · Received August 19, 2011

    Report

    Report Number
    1820334-2011-00441
    Event Type
    Injury
    Date Received
    August 19, 2011
    Report Date
    July 21, 2011
    Manufacturer
    COOK, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K060174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXP DATE UNK AS LOT IS UNK. LOT # WAS NOT PROVIDED BY REPORTER. (B)(4) - EMPHYSEMA UNDER THE SKIN IS NOT ADDRESSED IN THE IFU. (B)(4) - SEPARATES IS NOT ADDRESSED IN THE IFU. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PT WAS WEARING 5 LUMEN SPECTRUM CVC FOR SOME DAYS. BOTH PTS (ALSO REFERENCE 1820334-2011-00440) WAS CONFUSED AND WHILE MOVING, THE EXTENSION OF THE CVC WAS SNAGGED ON SOMETHING AND THE RED PART OF THE MSW DISCONNECTED FROM THE WHITE PART. BECAUSE OF THE TRACTION, THE CVC CAME OUT OF THE PT UP TO THE LAST MM. THE TIP OF THE CVC NOW WAS LOCATED UNDERNEATH THE SKIN OR INSIDE THE TISSUE BETWEEN SKIN AND VESSEL ALSO THE INFUSION SOLUTION. THE PT GOT AN EMPHYSEMA UNDERNEATH THE SKIN. PT OUTCOME IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETE FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK