BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARROW PICC LINE

    MDR report key: 113857 · Received August 14, 1997

    Report

    Report Number
    113857
    Event Type
    Other
    Date Received
    August 14, 1997
    Date of Event
    August 3, 1997
    Report Date
    August 6, 1997
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PICC WAS INSERTED AS A REPLACEMENT FOR A PREVIOUS PICC THAT HAD BEEN NOTED TO LEAK FROM AN EXTERNAL PORTION OF THE CATHETER. THE NEW PICC WAS INSERTED 7/31/97 AND WAS FOUND TO BE LEAKING FROM AN EXTERNAL STRESS POINT ON 8/3/97. THIS CATHETER WAS REMOVED AND REPLACED WITH A NEW PICC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW PICC LINE TWO LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER DQO ARROW INTERNATIONAL, INC. PR05052 R1197

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other