BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M

    MDR report key: 5101402 · Received October 25, 2004

    Report

    Report Number
    5101402
    Event Type
    Other
    Date Received
    October 25, 2004
    Date of Event
    September 20, 2004
    Report Date
    October 18, 2004
    Manufacturer
    SMITH MEDICAL
    Product Code
    FPA
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PT WITH CORONARY ARTERY DISEASE. REG HEART CATHETERIZATION. PLACED ON HEPARIN POST PROCEDURE PENDING SURGICAL INTERVENTION. BOLUSED WITHIN 5,000 UNITS HEPARIN. DRIP RATE SET AT 1,000 UNITS/HR (20CC), 25,000 UNITS INFUSED WITHIN 4 HOURS. NO OCCULT BLEEDING OCCURRED. PT MONITORED ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M INFUSION TUBING FPA SMITH MEDICAL NA JUNO4T05

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other