BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CLAMP

    MDR report key: 145618 · Received January 20, 1998

    Report

    Report Number
    1648571-1998-00004
    Event Type
    Malfunction
    Date Received
    January 20, 1998
    Date of Event
    December 19, 1997
    Report Date
    January 16, 1998
    Manufacturer
    QFC PLASTICS
    Product Code
    HFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BABY WAS CLAMPED ON UMBILICAL CORD BUT THE CLAMP SLIPPED OFF. THE BABY LOST APPROX 50 CC OF BLOOD. TESTING WAS PERFORMED TO ASSURE BABY HAD ENOUGH BLOOD. 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