BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAMIC DECA

    MDR report key: 3102089 · Received April 23, 2013

    Report

    Report Number
    1222791-2013-00002
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    February 5, 2013
    Report Date
    April 2, 2013
    Manufacturer
    C.R. BARD INC. (BEP)
    Product Code
    DRF
    PMA / PMN Number
    K921872A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER COULD NOT REMOVE THE CATHETER FROM THE CORONARY SINUS. THE PATIENT HAD GENERAL ANESTHESIA AND THE USER SUCCEEDED IN THE REMOVAL OF THE DEVICE WITHOUT SURGERY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174104 DYNAMIC DECA DRF C.R. BARD INC. (BEP) REWJ0745

    Patients

    Seq Age Sex Outcome Treatment
    1