BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.9FX50CM VASCU-PICC

    MDR report key: 2121736 · Received May 19, 2011

    Report

    Report Number
    2518902-2011-00052
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 "PICC CRACKED BETWEEN THE WHITE LUER LOCK AND THE CLEAR TUB PART OF THE PICC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9FX50CM VASCU-PICC INFUSION CATHETER, PICC LJS MEDCOMP MR17011101 MBDD650

    Patients

    Seq Age Sex Outcome Treatment
    1 71 DA Required Intervention MICROCLAVE CONNECTOR