BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6FX60CM TRPL LMN PRO PICC

    MDR report key: 2121752 · Received May 19, 2011

    Report

    Report Number
    2518902-2011-00054
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE YELLOW LUMEN SHOWED LEAKAGE, APPROXIMATELY ONE WEEK AFTER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6FX60CM TRPL LMN PRO PICC INFUSION CATHETER-PICC LJS MEDCOMP MR17036305 MAXZ590

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention