BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTROD

    MDR report key: 3832833 · Received March 17, 2014

    Report

    Report Number
    3006260740-2014-00126
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    August 29, 2011
    Report Date
    March 13, 2014
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TOT HE MANUFACTURER FOR EVALUATION, AS THE DEVICE DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED "HICKMAN INSERTED (B)(6) 2011. SUTURES REMOVED (B)(6) 2011. LINE FELL OUT 9 DAYS LATER. THIS PATIENT WAS A PULMONARY HYPERTENSIVE PATIENT WHO HAD A LIFE SAVING INFUSION RUNNING THROUGH THE LINE 24 HOURS A DAY AND THEREFORE WHEN THE LINE BECAME DISLODGED, IT WAS AN EMERGENCY. AS A CONSEQUENCE, WHEN THIS PATIENT HAS A HICKMAN LINE INSERT, THE DOCTOR IS NOW ADVISING TO LEAVE THE SUTURES IN FOR AS LONG AS POSSIBLE (6-12 WEEKS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156850 HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTROD LJS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention