BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE VENOUS ACCESS DEVICE

    MDR report key: 36809 · Received August 30, 1996

    Report

    Report Number
    1618732-1996-00002
    Event Type
    Injury
    Date Received
    August 30, 1996
    Report Date
    August 5, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    DQO
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 MANUFACTURE AND SALE OF THE STREAMLINE LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 09/18/96. FACILITY'S 3500A FORM, ATTACHED, RECEIVED BY MANUFACTURER ON 09/24/96.

    Description of Event or Problem · 1

    DEVICE WAS INSERTED AND THREADED EASILY INTO LEFT CEPHALIC VEIN USING A FLOAT IN TECHNIQUE BY WHICH SALINE WAS USED TO FLUSH AT THE SAME TIME THE CATHETER WAS ADVANCED. THE CATHETER WAS IN PLACE 2-3 MINUTES AND THEN WITHIN 30-60 SECONDS AFTER THE HEPARIN FLUSH, THE PT EXPERIENCED HEAD AND NECK FLUSHING, A BITTER TASTE IN THE MOUTH, A "LUMP" IN THE BACK OF THE THROAT, A DROP IN BLOOD PRESSURE AND AN INCREASED PULSE RATE. ABOUT AN HOUR LATER ANGIOEDEMA OF THE THROAT AND UVULA WAS NOTED AS WELL AS ARM SWELLING AT THE DEVICE INSERTION SITE AND THE FOREARM. SYMPTOMS GRADUALLY IMPROVED AFTER THE DEVICE WAS REMOVED AND THE BENADRYL ADMINISTERED. PT DENIED ANY RESPIRATORY DISTRESS OR DIFFICULTY. ANOTHER MFR'S CATHETER WAS PLACED IN THE LEFT WRIST, FLUSHED WITH HEPARIN AND RESULTED IN SWELLING OF THE FOREARM. ANGIOEDEMA DID NOT WORSEN, THE PT IMPROVED AND WAS DISCHARGED 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE VENOUS ACCESS DEVICE MIDLINE VENOUS ACCESS DEVICE DQO MENLO CARE, INC. NA 5091911M

    Patients

    Seq Age Sex Outcome Treatment
    1 *