BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6833 UMBILICAL CORD CLAMP, 100/CS

    MDR report key: 280705 · Received May 31, 2000

    Report

    Report Number
    1046367-2000-00021
    Event Type
    Malfunction
    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

    PREMATURE INFANT, 26 WEEKS, 1 LB. 7 OZ., UMBILICAL CORD CLAMP SLIDE UP AND DOWN ON UMBILICAL CORD; WOULD NOT CLAMP CORD. USER FACILITY APPLIED NEW CLAMP. NO BLOOD LOSS RESULTED FROM INCIDENT, AND NO PT INJURY OCCURRED.

    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 Other