BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5FX55CM DL PRO PICC CT

    MDR report key: 2121718 · Received May 19, 2011

    Report

    Report Number
    2518902-2011-00055
    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 MFG RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC WAS REMOVED AFTER LEAKAGE IN THE LINE JUST BEFORE THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5FX55CM DL PRO PICC CT INFUSION CATHETER-PICC LJS MEDCOMP MR17035205 MBCG530

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention