BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURIAN

    MDR report key: 72427 · Received March 3, 1997

    Report

    Report Number
    MW1010859
    Event Type
    Malfunction
    Date Received
    March 3, 1997
    Report Date
    February 25, 1997
    Manufacturer
    ALPHA INDUSTRIES, INC.
    Product Code
    HFW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A C-SECTION, THE PLASTIC UMBILICAL CORD CLAMP BROKE OFF, ENTERING THE STERILE FIELD. DR WAS UNABLE TO CLAMP THE CORD. FACILITY HAS HAD APPROX 10 OCCURRENCES IN THE PREVIOUS 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURIAN UMBILICAL CORD CLAMP HFW ALPHA INDUSTRIES, INC. * S12306

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other