BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CLAMP

    MDR report key: 139610 · Received December 5, 1997

    Report

    Report Number
    1648571-1997-00007
    Event Type
    Malfunction
    Date Received
    December 5, 1997
    Date of Event
    November 8, 1997
    Report Date
    December 5, 1997
    Manufacturer
    QFC PLASTICS
    Product Code
    HFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFANT WAS APPROX 1 HR OLD AND HAD BEEN MOVED TO THE NURSERY. UPON ROUTINE CHARTING IT WAS NOTICED THAT BLOOD WAS LEAKING THROUGH THE INFANT'S WRAPPER. THE CLAMP WAS EXAMINED AND DETERMINED TO HAVE PARTICALLY OPENED. THE DELIVERY WAS NORMAL, HOWEVER, THERE WAS NOT MUCH CORD LEFT TO PLACE ANOTHER CLAMP. CBC WAS TAKEN AND INFLANT WAS LATER RELEASED TO GO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILICAL CLAMP UMBILICAL CLAMP HFW QFC PLASTICS QFC-650 163-97

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention