BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HICKMAN 7FR D/L/CVC, PEEL-APART INTRO KIT W/SUREFCUFF TISSUE

    MDR report key: 3012449 · Received March 14, 2013

    Report

    Report Number
    3006260740-2013-00118
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 4, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE REMAINS IN THE PATIENT. A LOT HISTORY REVIEW (LHR) OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO E.D. WITH FEVER ON (B)(6) 2013. BLOOD CULTURES WERE DRAWN AT THIS TIME. FOLLOW-UP VISIT IN PEDS INFUSION ON (B)(6) 2013 RN NOTED A BULGING AREA ON PATIENT SIDE OF WHERE HICKMAN Y TURNS INTO A DOUBLE LUMEN. BLOOD CULTURES CAME BACK AS POSITIVE APPROXIMATELY 48 HOURS LATER. (B)(6) REPAIRED LINE. ANTIBIOTICS STARTED. NATURE OF INJURY: INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108168 HICKMAN 7FR D/L/CVC, PEEL-APART INTRO KIT W/SUREFCUFF TISSUE LJS C. R. BARD INC. (BASD) HUWA1522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention