BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CLAMP

    MDR report key: 145630 · Received January 20, 1998

    Report

    Report Number
    1648571-1998-00001
    Event Type
    Malfunction
    Date Received
    January 20, 1998
    Report Date
    January 16, 1998
    Manufacturer
    QFC PLASTICS
    Product Code
    HFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE BABY WITH THIN UMBILICAL CORD WAS CLAMPED BUT THE CORD ALMOST SLIPPED OUT OF THE CLAMP. THERE WAS SOME BLEEDING SO TESTING WAS PERFORMED (BLOOD COUNTS). THE BABY WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILICAL CLAMP UMBILICAL CLAMP HFW QFC PLASTICS QFC-650 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention