BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6FX60CM TRPL LMN PRO PICC

    MDR report key: 1663340 · Received April 9, 2010

    Report

    Report Number
    2518902-2010-00028
    Event Type
    Malfunction
    Date Received
    April 9, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 9, 2010
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT AN EVAL OF THE DEVICE INVOLVED WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LUER WAS FOUND DETACHED FROM THE EXTENSION TUBING. THE PICC WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6FX60CM TRPL LMN PRO PICC CT PICC LJS MEDCOMP MR17036301 MAYC350

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention