BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERMARK PERIPHERLLY INSERTED CENTRAL CATHETER

    MDR report key: 38529 · Received September 13, 1996

    Report

    Report Number
    1618732-1996-00022
    Event Type
    Injury
    Date Received
    September 13, 1996
    Date of Event
    July 26, 1996
    Report Date
    September 9, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 10/11/96. H2 - JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 9/18/96.

    Description of Event or Problem · 1

    AFTER THE DEVICE WAS INSERTED WITHOUT DIFFICULTY AND BEFORE THE GUIDE WIRE HAD BEEN REMOVED, THE PT BECAME TACHYCARDIC, HAD A CHANGE IN CONSCIOUSNESS AND HAD SOME TROUBLE BREATHING. THE PT REMAINED RESPONSIVE AND NEEDED "EPINEPHRINE AND INTRAVENOUS FLUID BOLUS" BEFORE BEING TRANSFERRED TO THE ICU TO BE MONITORED AND RECEIVE ADD'L MEDICATIONS (STEROID OR ANTIHISTAMINES). THE PT RECOVERED SHORTLY AND WAS DISCHARGED HOME WITH THE LINE IN PLACE FOR ANTIBIOTIC THERAPY. 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 PERIPHERLLY INSERTED CENTRAL CATHETER PERIPHERALLY INSERTED CENTRAL CATHETER DQO MENLO CARE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention DURING INSERTION OF THE DEVICE ON THE DAY OF THE| LIDOCAINE SOLUTION SUBCUTANEOUS FOR LOCAL ANESTHES
    2 EVENT.