BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED TRIFUSION CATHETER

    MDR report key: 3123978 · Received May 15, 2013

    Report

    Report Number
    3006260740-2013-00226
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 2, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PT HAD HIS CATHETER CHANGED FOR AN ISSUE WITH 2 BROKEN CLAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214850 IMPLANTED TRIFUSION CATHETER LONG TERM INTRAVASCULAR CATHETER LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention