BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER

    MDR report key: 2062924 · Received March 21, 2011

    Report

    Report Number
    3006260740-2011-00085
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    April 18, 2010
    Report Date
    March 1, 2011
    Manufacturer
    C. R. BARD INC., (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR OF LOT # HUTG1705 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    CATHETER BREAK. NO OTHER DETAILS AVAILABLE AS EVENT HAPPENED 11 MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER LJS C. R. BARD INC., (BASD) HUTG1705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention