BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AM PICC SET: 1-L 4.5FR X 55CM 80CM HYDRO

    MDR report key: 5032032 · Received August 26, 2015

    Report

    Report Number
    1036844-2015-00380
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 29, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K112896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS PLACED INTO THE PATIENT ON (B)(6) 2015 IN THE RADIOLOGY DEPARTMENT. THE LINE WAS CONSIDERED TO BE THE CAUSE OF A CENTRAL LINE ASSOCIATED BLOODSTREAM INFECTION AND WAS REMOVED ON (B)(6) 2015. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563580 AM PICC SET: 1-L 4.5FR X 55CM 80CM HYDRO PERIPHERALLY INSERTED CATHETER PRODU LJS ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening