BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2591879 · Received May 24, 2012

    Report

    Report Number
    9610847-2012-00043
    Event Type
    Death
    Date Received
    May 24, 2012
    Date of Event
    January 16, 2012
    Report Date
    May 23, 2012
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(6) WAS NOTIFIED AND OBSERVED THE BD Q-SYTE DEVICE ATTACHED TO THE CENTRAL LINE. (B)(6) CONTACTED (B)(4) REGARDING THE INCIDENT. THE CUSTOMER HAS NOT COMPLAINED ABOUT THE BD Q-SYTE DEVICE, NOR HAVE THEY CONTACTED BD (B)(4) REGARDING THIS MATTER. COVIDIEN ATTEMPTED TO OBTAIN ADD¿L INFO REGARDING THE INCIDENT: THE PT¿S MEDICAL HISTORY, AND CAUSE OF DEATH, HOWEVER, NO ADD¿L INFO WAS RECEIVED. IT IS ALSO UNK WHERE THE SAMPLES AT THIS POINT (I.E. IF THE HOSPITAL STILL HAS IT, OR IF IT HAS BEEN DISCARDED), AS THE CUSTOMER HAS HALTED COMMUNICATIONS WITH COVIDIEN AND BD (B)(4) REGARDING THE INCIDENT. RESULTS ¿ NO ADD¿L INFO REGARDING THIS INCIDENT IS AVAILABLE. THE SAMPLE WILL NOT BE RECEIVED FOR EVAL AS THE CUSTOMER HAS HALTED COMMUNICATIONS. WITHOUT A LOT NUMBER, A REVIEW OF THE DEVICE HISTORY RECORDS AND MATERIAL REVIEW REPORT DATABASE COULD NOT BE PERFORMED. CONCLUSIONS: WITHOUT A SAMPLE, WE ARE UNABLE TO CONFIRM ANY DAMAGE TO THE BD Q-SYTE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012 A SMAC PLUS CV LINE, MADE BY COVIDIEN (CATALOG NUMBER 1316-12G) WAS INSERTED INTO THE PT. A BD Q-SYTE WAS CONNECTED TO THE CATHETER HUB. THE LINE WAS THEN FILLED WITH HEPARIN. ON (B)(6) 2012, THE PT¿S CONDITION SUDDENLY CHANGED AND THE PT PASSED AWAY. AFTER THE PT¿S DEATH, THE CUSTOMER FIRST CONTACTED COVIDIEN FOR INVESTIGATION OF THE LINE. THE CUSTOMER DID NOT BELIEVE THE LINE WAS RELATED TO THE DEATH, BUT WANTED THE CONDITION OF THE SAMPLE CHECKED. COVIDIEN TOOK PHOTOS OF THE SAMPLE, HOWEVER, THE CUSTOMER REQUESTED IMMEDIATE RETURN OF THE SAMPLE AND NO INVESTIGATION WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death