BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDCOMP PICC

    MDR report key: 1063110 · Received June 19, 2008

    Report

    Report Number
    MW5007361
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 14, 2008
    Report Date
    June 19, 2008
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DIRECTOR OF QUALITY AND RISK MANAGEMENT REPORTS THAT THE PICC LINE THAT WAS INSERTED IN THE PATIENT HAD A CRACK AT THE RED PORT AND LEAKED WHEN THE NURSE TRIED TO FLUSH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCOMP PICC DOUBLE LUMEN PACK PICC LINE LJS MAPL1102

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR