BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3F X 60CM SINGLE VASCU-PICC

    MDR report key: 1853784 · Received September 3, 2010

    Report

    Report Number
    2518902-2010-00063
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A HOLE IN THE EXTENSION WHERE THE LUER IS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3F X 60CM SINGLE VASCU-PICC INFUSION CATHETER LJS MEDCOMP MR17013101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK