BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4FR PICC BASIC TRAY

    MDR report key: 396521 · Received May 23, 2002

    Report

    Report Number
    1720496-2002-00102
    Event Type
    Injury
    Date Received
    May 23, 2002
    Date of Event
    March 20, 2002
    Report Date
    April 26, 2002
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON REMOVAL LINE WAS FOUND TO BE LEAKING. LINE INSERTED UNDER X-RAY IMAGING AND FUNCTIONED WITHOUT ANY PROBLEMS. 27 DAYS LATER SURROUNDING SKIN APPEARED INFLAMED. THIS WAS THOUGHT TO BE DUE TO A SENSITIVITY TO HAVE V300 OPSITE DRESSING. THE DRESSING WAS REPLACED BY A TEGADERM DRESSING BUT IMPROVEMENT DID NOT OCCUR. FINALLY THE OCCLUSIVE DRESSINGS WERE OMITTED AND A BANDAGE APPLIED. IN 03/2002 THERE WAS EVIDENCE OF A BRIGHT GREEN ADORLESS DISCHARGE WHICH WAS SUBSEQUENTLY SWABBED, NO GROWTH WAS CULTURED BUT THE SKIN CONDITION DETERIORATED. 24 DAYS LATER THE LINE WAS PREMATURELY REMOVED AND FOUND TO BE LEAKING. THE PATIENT HAD UNDERGONE 10 WEEKS OF INFUSION 5 FLUROURACIL CHEMOTHERAPY. PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4FR PICC BASIC TRAY LONG TERM INTRAVASCULAR CATHETER DQO BARD REYNOSA S.A. DE C.V. 7715405 22BL5293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other