BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CLAMP

    MDR report key: 139702 · Received December 5, 1997

    Report

    Report Number
    1648571-1997-00006
    Event Type
    Malfunction
    Date Received
    December 5, 1997
    Date of Event
    October 29, 1997
    Report Date
    December 5, 1997
    Manufacturer
    QFC PLASTICS
    Product Code
    HFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OVER THE LAST MONTH VARIOUS PHYSICIANS HAVE USED THIS CLAMP AND IT HAS OPENED AFTER CLOSURE ON BABY'S UMBILICAL CORD. THIS INCIDENT ON 10/29/97 INVOLVED SOME BLEEDING ON THE PART OF THE NEWBORN. THE DELIVERY WAS VERY NORMAL AND DURING THE RECOVERY TIME THE MOTHER WAS NURSING HER NEWBORN AND NOTED BLEEDING. UPON EXAMINATION OF THE INFANT IT WAS DETERMINED THAT THE CORD CLAMP HAD SLID OFF. ANOTHER CLAMP WAS IMMEDIATELY PLACED ON THE INFANT AND A FULL CBC WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILICAL CLAMP UMBILICAL CLAMP HFW QFC PLASTICS QFC-650 183-97

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention