BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    72-7000 CORD CLAMP CUTTER

    MDR report key: 390705 · Received April 22, 2002

    Report

    Report Number
    1046367-2002-00058
    Event Type
    Malfunction
    Date Received
    April 22, 2002
    Date of Event
    January 1, 2002
    Report Date
    March 21, 2002
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    JOK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CORD CLAMP CUTTER BROKE WHEN THEY WERE TRYING TO CUT THE CLAMP. IT BROKE AT THE TOP PLASTIC PIECE AND EXPOSED THE BLADE. THE NURSE STATED THAT THIS COULD HAVE PULLED AND CUT THE UMBILICAL CORD CAUSING THE PT TO BLEED. THIS OCCURRED 2 TIMES AT THIS FACILITY (A SEPARATE COMPLAINT WILL BE FILED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 72-7000 CORD CLAMP CUTTER UMBILICAL CORD CLAMP CUTTER JOK DEROYAL INDUSTRIES, INC. NA NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN