BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4F SINGLE PICC

    MDR report key: 1051540 · Received May 16, 2008

    Report

    Report Number
    2518902-2008-00024
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    March 12, 2008
    Report Date
    May 16, 2008
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECORD REVIEW - A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECS AND QUALITY REQUIREMENTS WERE SATISFIED. NO SAMPLE WAS RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "LUER ON THE PICC, WHERE THE NEEDLE LESS CONNECTOR IS ATTACHED, IS COMING OFF OF THE CLEAR EXTENSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4F SINGLE PICC VASCU-PICC LJS MEDCOMP COR4S MAMK790

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention