BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED VENOUS ACCESS

    MDR report key: 269833 · Received March 17, 2000

    Report

    Report Number
    6000002-2000-00075
    Event Type
    Malfunction
    Date Received
    March 17, 2000
    Date of Event
    February 8, 2000
    Report Date
    February 17, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    JCY
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STYLET ON THE OBTURATOR FROM AN AVA KIT BROKE AT THE HUB WHILE IN VIVO ON A "DO NOT RESUSCITATE" PT. IT WAS REPORTED THAT THE PT LATER DIED OF MULTIPLE ORGAN FAILURES UNRELATED TO THE DEVICE. THE OBTURATOR WAS INSERTED WHEN THE SWAN-GANZ CATHETER WAS DISCONTINUED. WHEN THE AVA CATHETER WAS DISCONTINUED, IT WAS NOTED THAT 7 CM OF THE OBTURATOR STYLET WAS MISSING. IT WAS STATED THAT THE PT'S EXPIRATION IS UNRELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED VENOUS ACCESS CENTRAL VENOUS ACCESS CATHETER JCY BAXTER HEALTHCARE CORP. M3L9FHKI 949M0974

    Patients

    Seq Age Sex Outcome Treatment
    1 Other