BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 1366456 · Received April 14, 2009

    Report

    Report Number
    1366456
    Event Type
    Malfunction
    Date Received
    April 14, 2009
    Date of Event
    March 13, 2009
    Report Date
    April 14, 2009
    Manufacturer
    OWENS & MINOR
    Product Code
    HFW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLADE ON CORD CLAMP REMOVER DISLODGED WHILE REMOVING CLAMP,WHICH BECAME STUCK ON CLAMP WHILE ATTACHED TO THE BABY. THE BLADE WAS LOOSE, BUT DEVICE COULD NOT BE REMOVED FROM THE NEWBORN. THIS POSED A DANGER TO THE BABY AND TOOK MUCH EFFORT FROM THREE RNS TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE CORD CLAMP REMOVER, UMBILICAL HFW OWENS & MINOR * CCG09-31

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA