BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 492858 · Received October 10, 2003

    Report

    Report Number
    492858
    Event Type
    Injury
    Date Received
    October 10, 2003
    Date of Event
    May 26, 2003
    Report Date
    September 22, 2003
    Manufacturer
    ABBOTT CRITICAL CARE SYSTEMS
    Product Code
    DRS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NECROTIC SORE DEVELOPED ABOUT 3 INCHES ABOVE THE INSERTION SITE OF AN ARTERIAL LINE INSERTED AT THE PT'S WRIST FOR BLOOD PRESSURE MONITORING. THE ARTERIAL LINE IS ALSO USED FOR PERIODIC BLOOD DRAAWS AND INCLUDES A CELL-SAVER DEVICE. THIS IS ONE OF SIX SIMILAR CASES AT THIS FACILITY IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT ICU DISPOSABLE TRANSDUCER DRS ABBOTT CRITICAL CARE SYSTEMS * 944255G
    10 COOK CATH RADIAL ARTERY SET DQY COOK INC * 1212839
    11 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 1212840
    12 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 1216350
    13 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 1216352
    14 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 1218126
    15 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 1220911
    16 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 1223899
    17 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 1225682
    18 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 1227767
    19 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 1230222
    2 ABBOTT ICU DISPOSABLE TRANSDUCER DRS ABBOTT CRITICAL CARE SYSTEMS * 934385G
    20 COOK CATH RADIAL ARTERY SET DQY COOK INC * 1232311
    21 COOK CATH RADIAL ARTERY SET DQY COOK INC * 1239620
    22 COOK CATH RADIAL ARTERY SET DQY COOK INC * 1239621
    23 COOK CATH RADIAL ARTERY SET DQY COOK INC * 03121JT
    24 COOK CATH RADIAL ARTERY SET DQY COOK INC * 03164JT
    25 COOK CATH RADIAL ARTERY SET DQY COOK, INC * 03189JT
    26 COOK CATH RADIAL ARTERY SET DQY COOK INC * 04115JT
    27 COOK CATH RADIAL ARTERY SET DQY COOK INC * 04188JT
    28 COOK CATH RADIAL ARTERY SET DQY COOK INC * 04190JT
    3 ABBOTT ICU DISPOSABLE TRANSDUCER DRS ABBOTT CRITICAL CARE SYSTEMS * 954125G
    4 ABBOTT BLOOD SAMPLING TRAY JKA ABBOTT LABORATORIES * 94227SN
    5 ABBOTT BLOOD SAMPLING TRAY JKA ABBOTT LABORATORIES * 93314SN
    6 ABBOTT BLOOD SAMPLING TRAY JKA ABBOTT LABORATORIES * 95107SN
    7 COOK CATH RADIAL ARTERY SET DQY COOK INC * 1199096
    8 COOK CATH RADIAL ARTERY SET DQY COOK INC * 1201549
    9 COOK CATH RADIAL ARTERY SET DQY COOK INC * 1207013

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention HEPARIN SODIUM 1000 USP UNITS IN 0.9% NACL 500ML| ANTICOAGULATION| INTRAVENOUS
    2 *