BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6833 UMBILICAL CORD CLAMP, 100/CS

    MDR report key: 280301 · Received May 31, 2000

    Report

    Report Number
    1046367-2000-00019
    Event Type
    Injury
    Date Received
    May 31, 2000
    Date of Event
    May 2, 2000
    Report Date
    May 31, 2000
    Manufacturer
    DEROYAL
    Product Code
    HFW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCIDENT OCCURRED ABOUT 15 MINUTES AFTER CORD CLAMPING. WHILE THE INFANT WAS UNDER THE WARMER, NURSE NOTICED BLOOD FLOWING THROUGH THE CORD CLAMP. NURSE APPLIED PRESSURE TO THE CORD AND PLACED A NEW CLAMP ON THE CORD, WHICH STOPPED THE BLOOD FLOW. INFANT LOST ABOUT 1CC BLOOD, AND REQUIRED NO ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6833 UMBILICAL CORD CLAMP, 100/CS 7N8 UMBILICAL CORD CLAMP HFW DEROYAL 07 194854

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Life Threatening