BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KELLY CLAMP

    MDR report key: 3273393 · Received July 17, 2013

    Report

    Report Number
    3273393
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 17, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    NMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    KELLY CLAMP WAS HANDED TO DOCTOR BY CERTIFIED SURGICAL TECHNOLOGIST (CST) AT DELIVERY TO CLAMP THE UMBILICAL CORD TO OBTAIN A SEGMENT OF CORD BLOOD. THE HEAD OF THE CLAMP BROKE AWAY FROM THE BODY OF THE CLAMP WHEN SHE ATTEMPTED TO LOCK THE HANDLE. THE INSTRUMENT AND BROKEN CLAMP HEAD WAS REMOVED OFF FIELD, HANDED TO RN CIRCULATOR, AND DOUBLE BAGGED IN BIOHAZARD BAG WITH PATIENT'S LABEL. RN HANDED THE BAGGED INSTRUMENT TO CHARGE RN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331367 KELLY CLAMP CLAMP, VASCULAR, REPROCESSED NMF INTEGRA LIFESCIENCES CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR