BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE CATHETER

    MDR report key: 37164 · Received September 9, 1996

    Report

    Report Number
    MW4001482
    Event Type
    Injury
    Date Received
    September 9, 1996
    Date of Event
    August 30, 1995
    Report Date
    September 5, 1995
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED HIVES ON LEGS AND ABDOMEN IMMEDIATELY AFTER PLACEMENT ON 8/30. 25MG PO BENADRYL GIVEN AND 25 MG BENADRYL GIVEN IVP W/IN 10 MINS AND HIVES SUBSIDED. HAD ONLY USED 20ML OF NS FLUSH IV AND 5CC OF 100U/ML HEPARIN IV WITH CATHETER BEFORE IT WAS DC'D. CATHETER WAS IN L BASILIC VEIN. A TOTAL OF APPROX 15 MINS BEFORE IT WAS DC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE CATHETER MIDLINE CATHETER 22G 6" FOZ MENLO CARE, INC. 22G 6" CATH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention