BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW MULTI-LUMEN CATHETER

    MDR report key: 202925 · Received December 16, 1998

    Report

    Report Number
    1036844-1998-00147
    Event Type
    Injury
    Date Received
    December 16, 1998
    Date of Event
    June 3, 1997
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT, WITH A KNOWN HISTORY OF ALLERGY, SUFFERED CONVULSIONS AND CARDIO-PULMONARY ARREST AFTER THE CATHETER WAS INSERTED VIA THE SUBCLAVIAN. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED AND MEDICATIONS GIVEN FOR SHOCK. THE PT WAS RESUSCITATED AND THE CATHETER WAS REMOVED. THE PT DEVELOPED ENCEPHALOPATHY AND REQUIRED A LEG AMPUTATION DUE TO GANGRENE. ALL ARROWGARD CENTRAL VENOUS CATHETERS WERE REMOVED FROM HOSPITALS IN 9/1997. THIS EVENT OCCURRED PRIOR TO THE PRODUCT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW MULTI-LUMEN CATHETER CENTRAL VENOUS CATHETER/ARROWGARD COAT. DQO ARROW INTERNATIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention