BEUDAMED
    FDA Adverse Event Injury Summary report: N

    006225P-5F 115 COURN SEM FLOAT

    MDR report key: 452476 · Received April 9, 2003

    Report

    Report Number
    1222791-2003-00001
    Event Type
    Injury
    Date Received
    April 9, 2003
    Report Date
    April 9, 2003
    Manufacturer
    C.R. BARD, INC. (GLENS FALLS)
    Product Code
    LDF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE TPE WAS IN USE, ONE YELLOW SAFETY ADAPTER BECAME LOOSE WITHOUT MANIPULATION. THE PATIENT WENT INTO COMPLETE ASYSTOLE AND HAD TO BE RE-ANIMATED. AN UNUSED SAMPLE FROM THE SAME LOT WILL BE SENT BACK FOR EVALUATION. ACTUAL SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 006225P-5F 115 COURN SEM FLOAT 124050141-SEMI-FLOATING LDF C.R. BARD, INC. (GLENS FALLS) NA 07BM2577

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention