BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN 12 FR DL CVC, PEEL-APART INTRODUCER KIT WITH SU

    MDR report key: 1489256 · Received July 28, 2009

    Report

    Report Number
    3006260740-2009-00272
    Event Type
    Malfunction
    Date Received
    July 28, 2009
    Date of Event
    June 26, 2009
    Report Date
    July 3, 2009
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 17 DAYS AFTER IMPLANTATION, DURING NPP INFUSION THROUGH THE CATHETER, THE PT PRESENTED EDEMA, PAIN AND HEAT NEAR THE CATHETER INSERTION SITE IN THE SUBCLAVIAN VEIN. WHEN THE CATHETER WAS REMOVED, THEY SAW A LEAK FROM THE CATHETER AFTER SALINE SOLUTION INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN 12 FR DL CVC, PEEL-APART INTRODUCER KIT WITH SU LJS C. R. BARD INC. (BASD) HURF1039

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention