BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANCED VENOUS ACCESS CATHETER

    MDR report key: 226048 · Received June 4, 1999

    Report

    Report Number
    6000002-1999-00166
    Event Type
    Death
    Date Received
    June 4, 1999
    Date of Event
    May 7, 1999
    Report Date
    June 3, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    JCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS ADMITTED WITH SEVERE SEPTIC SHOCK. IT WAS STATED THAT THE CATHETER WAS INSERTED AND RESISTANCE WAS NOTED. FLUID WAS INFUSED THROUGH THE LINE. AN X-RAY WAS TAKEN AND THE CATHETER WAS REPOSITIONED. IT WAS REPORTED THAT A PNEUMOTHORAX OCCURRED; THE PT CODED AND EXPIRED. FOLLOWUP WITH THE PHYSICIAN INDICATED THAT THE REPORT IS NOT ATTRIBUTED TO THE CATHETER PER SE, HOWEVER MORE SECONDARY TO THE PT'S SUBCUTANEOUS CONDITION. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED VENOUS ACCESS CATHETER CENTRAL VENOUS ACCESS CATHETER JCY BAXTER HEALTHCARE CORP. M3L9FHK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death