BEUDAMED
    FDA Adverse Event Summary report: N

    WARMER DISPOSABLE SET

    MDR report key: 25411 · Received September 11, 1995

    Report

    Report Number
    MW1006895
    Date Received
    September 11, 1995
    Date of Event
    September 1, 1995
    Report Date
    September 8, 1995
    Manufacturer
    LEVEL 1 TECHNOLOGIES, INC.
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE IS DEFECTIVE AT SPIKE CAP JUNCTION TO DRIP CHAMBER. LEAKS, NO PT BLOOD LOSS, BUT POTENTIAL FOR CONTAMINATION OF STERILE AREA & HCP. CO NOTIFIED & TRYING TO RESPOND ASAP. 2ND REPORT FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMER DISPOSABLE SET WARMER FPA LEVEL 1 TECHNOLOGIES, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN