BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CLAMP

    MDR report key: 139618 · Received December 5, 1997

    Report

    Report Number
    1648571-1997-00008
    Event Type
    Malfunction
    Date Received
    December 5, 1997
    Date of Event
    October 31, 1997
    Report Date
    December 5, 1997
    Manufacturer
    QFC PLASTICS
    Product Code
    HFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ON SEVERAL OCCASIONS THE CORD CLAMP ALLOWED BLOOD LEAKAGE. THE INFANTS WERE JUST A FEW HRS OLD WHEN BLEEDING WAS NOTED. A SECOND CLAMP WAS APPLIED. ALL REPORTS INDICATED THAT POST SURGERY THE CLAMPS WERE SECURE, HOWEVER, THEY APPEARED TO NOT CLOSE TIGHT ENOUGH. NO MED TREATMENT OR ADD'L TESTING WERE PER FORMED.

    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