BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2020776 · Received March 8, 2011

    Report

    Report Number
    2020776
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    December 30, 2010
    Report Date
    March 4, 2011
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PICC LINE SNAPPED AT CONNECTION TO THE WHITE HUB COMPONENT DURING DRESSING CHANGE.====================== MANUFACTURER RESPONSE FOR PERIPHERALLY INSERTED CENTRAL CATHETER, 1.9 FR. X 50 CM SINGLE LUMEN PICC======================MANUFACTURER WILL EVALUATE ALL PICC LINES RETURNED AND WILL CREDIT HOSPITAL FOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, PICC LJS MEDCOMP * MBBA340

    Patients

    Seq Age Sex Outcome Treatment
    1 11 WK