BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERMARK PERIPHERALLY INSERTED CENTRAL

    MDR report key: 38736 · Received September 13, 1996

    Report

    Report Number
    2938241-1996-00004
    Event Type
    Injury
    Date Received
    September 13, 1996
    Date of Event
    August 9, 1996
    Report Date
    August 28, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT WAS SENT TO THE ER WHEN THE DEVICE COULD NOT BE REMOVED AT HOME AFTER THE COMPLETION OF THERAPY. HEAT WAS APPLIED UNSUCCESSFULLY. IN RADIOLOGY A GUIDE WIRE WAS INSERTED VIA FLUOROSCOPY. THE RADIOLOGIST WAS NOT ABLE TO REMOVE ANY LENGTH OF THE CATHETER. THE X-RAYS SHOWED THE CATHETER TO BE IN THE SUBCLAVIAN. THE PT STATED HE COULD FEEL "SOMETHING BUCKLING" IN THE BICEP AREA. A CUT DOWN WAS THEN DONE IN THE BICEP AREA AND THE CATHETER SUCCESSFULLY REMOVED. THE REPORTER STATES THAT THE SURGEON REPORTS, "THE CLEAR SILASTIC COATING WAS CRACKED ALL THE WAY AROUND. THERE WERE 2 LAYERS. FIBRIN HAD FORMED ALL AROUND AND INSIDE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTERMARK PERIPHERALLY INSERTED CENTRAL PERIPHERALLY INSERTED CENTRAL CATHETER DQO MENLO CARE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R CATHETER WAS INSERTED ON| REMOVED AFTER COMPLETION OF ANTIBIOTIC THERAPY