BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.6F X 50CM DUAL LUMEN PICC

    MDR report key: 2972021 · Received February 15, 2013

    Report

    Report Number
    2518902-2013-00008
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDCOMP
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WHEN THE INVESTIGATION IS COMPLETE A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    HOLE IN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69373 2.6F X 50CM DUAL LUMEN PICC INFUSION CATHETER, PICC DQO MEDCOMP MR17012601 MDPP170

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Required Intervention