BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL INC.

    MDR report key: 438735 · Received January 13, 2003

    Report

    Report Number
    MW1027291
    Event Type
    Malfunction
    Date Received
    January 13, 2003
    Date of Event
    December 16, 2002
    Report Date
    January 3, 2003
    Manufacturer
    ABBOTT DIAGNOSTICS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    WHEN TRYING TO PUSH GADOLINIUM THROUGH THE HEP LOCK DURING AN MRI, IT WOULD NOT GO THROUGH. IT WAS DISCOVERED THAT THE GADOLINIUM WAS BEING BLOCKED BY THE HUB FROM THE IV. THE INSIDE OF THE HEP LOCK CAP WAS IN THE TOP OF THE CONTRAST SYRINGE. IF THIS HAD BEEN INJECTED - SEVERE INJURY OR DEATH COULD HAVE RESULTED. THE HOSPITAL IS NOT SURE OF THE SPECIFIC MEDICAL DEVICE INVOLVED. THE HOSPITAL HAS BEEN TOLD IT WAS AN ABBOTT DEVICE CALLED THE CLAVE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MEDICAL INC. THE CLAVE CONNECTOR FPA ABBOTT DIAGNOSTICS REF11956 *
    2 LIFE SHIELD MICROBORE EXTENSION FPA ABBOTT DIAGNOSTICS N012094 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other