BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 1600969 · Received February 12, 2010

    Report

    Report Number
    1710034-2010-00005
    Event Type
    Death
    Date Received
    February 12, 2010
    Date of Event
    November 1, 2009
    Report Date
    January 25, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED ADDITIONAL INFORMATION FROM THE PATIENT FILE REGARDING THE INCIDENT. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4)

    Description of Event or Problem · 1

    THE FACILITY WAS CONTACTED ON 02/09/2010, FOR CLARIFICATION AND ADDITIONAL INFORMATION. THE HOSPITAL CONDUCTS HOURLY ROUNDS ON PATIENTS. WHEN THE NURSE ENTERED THE ROOM THE PATIENT WAS NOT BREATHING AND THE PRIMARY LINE (BD NEXIVA) HAD THE Y PORT BD Q-SYTE MISSING AND THERE WAS SIGNIFICANT AMOUNT OF BLOOD LOSS. ONE NURSE SUPERVISOR AND ONE MEDICAL DOCTOR CONFIRMED AT THE TIME THE AMOUNT OF BLOOD LOSS WAS NOT SUFFICIENT TO CAUSE THE CARDIAC ARREST AND THEREFORE, THE DEVICES (Q-SYTE/NEXIVA) WERE NOT THE CAUSE/ASSOCIATED WITH THE PATIENT'S DEATH. DEATH OCCURRED ON (B) (6) 2009. THIS WAS AN ELDERLY PATIENT, BUT THE RISK MANAGER DIDN'T HAVE ANY OTHER INFORMATION ON THE PATIENT (AGE, DIAGNOSIS, ETC) OR DEVICES (INDWELLING TIME, ETC) AT THIS TIME. (B) (4) IV TUBING WAS USED WITH THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD NEXIVA CLOSED IV ACCESS SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death HOSPIRA IV TUBING