BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BBL FIBROMETER

    MDR report key: 24324 · Received July 14, 1995

    Report

    Report Number
    24324
    Event Type
    Injury
    Date Received
    July 14, 1995
    Date of Event
    July 9, 1995
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY
    Product Code
    GIE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT WAS ON HEPARIN DRIP SINCE ADMISSION (7/7/95). CONTINUOUSLY MONITORED BY PTT'S LABWORK COAGULATION LEVELS. BOLUS DOSE WAS GIVEN BASED ON LAB VALUES. CLINICALLY DEMONSTRATED EVIDENCE OF MULTIPLE HEMATOMAS (BLEEDING). CONFIRMATION RECEIVED OF LAB PTT GREATER THAN 100 (PREVIOUSLY 30-40). HEPARIN WAS HELD AND PT WAS MONITORED CLOSELY WITH NO FURTHER EVIDENCE OF BLEEDING. MAINTAINED STATUS PAIN FREE AND HEMODYNAMICALLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL FIBROMETER PRECISION COAGULATION TIMER GIE BECTON DICKINSON MICROBIOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention