BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CLAMP

    MDR report key: 139668 · Received November 26, 1997

    Report

    Report Number
    1648571-1997-00004
    Event Type
    Malfunction
    Date Received
    November 26, 1997
    Date of Event
    October 19, 1997
    Report Date
    November 26, 1997
    Manufacturer
    QFC PLASTICS
    Product Code
    HFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFANT WAS LESS THAN 3 HOURS OLD. THE SURGEON HAD CLAMPED AND CUT THE UMBILICAL CORD. THE INFANT WAS THEN PASSED TO THE MOTHER TO SEE HER INFANT. THE NURSE TOOK THE INFANT APPROXIMATELY 4 FEET TO THE INFANT WARMER FOR ADDITIONAL CLEANING AND ROUTINE. THE RN TURNED TO COMPLETE THE INFANT'S CHART AND UPON RETURNING TO THE INFANT NOTICED BLEEDING THROUGH THE INFANT'S WRAP. UPON EXAMINATION IT WAS NOTICED THAT THE CORD CLAMP HAD OPENED PARTIALLY AND FELL OFF. A KELLY CLAMP WAS PLACED ON THE UMBILICAL CORD UNTIL ANOTHER CORD CLAMP WAS OBTAINED AND PLACED ON THE INFANT. NO ADDITIONAL MEDICAL TREATMENT WAS DONE.

    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