BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED GROSHONG PICC

    MDR report key: 3111601 · Received May 6, 2013

    Report

    Report Number
    3006260740-2013-00206
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    April 30, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. 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

    A FRACTURE OF THE CATHETER IN THE MIDDLE RESULTING IN INTENSE PAIN IN THE ARM OF AN OPD ONCOLOGY PATIENT NEEDING REMOVAL OF THE PICC LINE AND REINSERTION OF ANOTHER PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197499 IMPLANTED GROSHONG PICC PERCUTANEOUS IMPLANTED LONG TERM LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention