BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3240950 · Received July 17, 2013

    Report

    Report Number
    3006260740-2013-00347
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 24, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS IMPLANTED ON (B)(6) 2012. SHORTLY AFTER IMPLANTATION THE CATHETER LOST CONNECTION TO THE Y-HUB: THIS WAS REPAIRED SO THAT FUNCTION WAS GUARANTEED. THE CATHETER WAS EXPLANTED LAST WEEK WHEN THE THERAPY ENDED. THE CATHETER WAS BROKEN DIRECTLY AFTER THE Y-CONNECTION, BUT IT WAS REPAIRED POORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332115 HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER LJS C. R. BARD INC. (BASD) HUNB1225 (INVALID)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention