BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT. CATHETER SEGMENT FOR LEONARD 10FR ROUND D/L CVC REP

    MDR report key: 3012428 · Received March 14, 2013

    Report

    Report Number
    3006260740-2013-00117
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 20, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A LHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    PATIENT GO VERY ILL WHEN WHITE LUMEN OF CENTRAL LINE WAS FLUSHED. BLOOD PRESSURE AND HEART RATE BECAME ELEVATED, SHAKING CHILLS, TEMPERATURE OF 99.7F. (B)(6) GREW FROM BOTH THE WHITE AND RED LUMEN. PATIENT WAS ON IV ANTIBIOTICS FOR 16 DAYS. LINE REMAINS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108493 EXT. CATHETER SEGMENT FOR LEONARD 10FR ROUND D/L CVC REP LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention